Trial Outcomes & Findings for Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients (NCT NCT01611974)
NCT ID: NCT01611974
Last Updated: 2021-06-02
Results Overview
Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. This method was linear over 200-100,000 viral copies/mL with a lower limit of quantification (LLOQ) of 200 copies/mL. Results below LLOQ were considered undetectable. Confirmed undetectable plasma CMV DNA within 6 weeks was defined as 2 consecutive post-baseline, on-treatment undetectable results separated by \>/= 5 days (assessed by the central laboratory). Samples were collected on Days 1 and 8, weekly during Weeks 2-6, and once in Weeks 8, 10, 12, 16, 20, 24 (treatment) and Weeks 1, 4, 8, 12 (follow-up). Permissible assessment windows were: Days 8-15 +/- 1 day; Weeks 3-4 +/- 2 days; Weeks 5-6 +/- 3 days; Weeks 8-12 +/- 4 days; Weeks 16-24 +/- 7 days (treatment) and Weeks 1-4 +/- 2 days; Weeks 8-12 +/- 4 days (follow-up).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
6 weeks
Results posted on
2021-06-02
Participant Flow
Participant milestones
| Measure |
Maribavir 400 mg Twice Daily
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
40
|
|
Overall Study
COMPLETED
|
25
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
15
|
15
|
16
|
Reasons for withdrawal
| Measure |
Maribavir 400 mg Twice Daily
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Death
|
10
|
12
|
10
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
5
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
4
|
Baseline Characteristics
Maribavir for Treatment of Resistant or Refractory CMV Infections in Transplant Recipients
Baseline characteristics by cohort
| Measure |
Maribavir 400 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 14.25 • n=93 Participants
|
55.4 years
STANDARD_DEVIATION 14.13 • n=4 Participants
|
50.0 years
STANDARD_DEVIATION 12.96 • n=27 Participants
|
52.5 years
STANDARD_DEVIATION 13.86 • n=483 Participants
|
|
Age, Customized
18 to 44 years
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
|
Age, Customized
45 to 64 years
|
22 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
|
Age, Customized
65 to 75 years
|
7 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
25 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
69 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.
Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. This method was linear over 200-100,000 viral copies/mL with a lower limit of quantification (LLOQ) of 200 copies/mL. Results below LLOQ were considered undetectable. Confirmed undetectable plasma CMV DNA within 6 weeks was defined as 2 consecutive post-baseline, on-treatment undetectable results separated by \>/= 5 days (assessed by the central laboratory). Samples were collected on Days 1 and 8, weekly during Weeks 2-6, and once in Weeks 8, 10, 12, 16, 20, 24 (treatment) and Weeks 1, 4, 8, 12 (follow-up). Permissible assessment windows were: Days 8-15 +/- 1 day; Weeks 3-4 +/- 2 days; Weeks 5-6 +/- 3 days; Weeks 8-12 +/- 4 days; Weeks 16-24 +/- 7 days (treatment) and Weeks 1-4 +/- 2 days; Weeks 8-12 +/- 4 days (follow-up).
Outcome measures
| Measure |
Maribavir 400 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=38 Participants
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With Confirmed Undetectable Plasma Cytomegalovirus (CMV) Within 6 Weeks
|
28 participants
|
25 participants
|
27 participants
|
PRIMARY outcome
Timeframe: 25 weeksPopulation: The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.
Treatment-emergent adverse events are those events that occurred on or after study drug administration through 7 days after the last dose of study drug, or are events that occurred prior to study drug administration and recurred with increased severity after taking study drug through 7 days after the last dose of study drug.
Outcome measures
| Measure |
Maribavir 400 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With a Treatment Emergent Adverse Event (TEAE).
Any TEAE
|
40 participants
|
40 participants
|
40 participants
|
|
Number of Participants With a Treatment Emergent Adverse Event (TEAE).
Serious TEAE
|
28 participants
|
27 participants
|
26 participants
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.
Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. CMV recurrence was defined as achievement of undetectable plasma CMV DNA at any time after Day 1 in at least 2 consecutive samples separated by at least 5 days, followed by detectable plasma CMV DNA in at least 2 consecutive samples separated by at least 5 days (assessed by the central laboratory). For the analyses of CMV recurrence, the first of 2 consecutive confirmed undetectable plasma CMV DNA results had to be on-treatment. CMV DNA PCR values of ≥200 copies/mL were considered detectable. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects.
Outcome measures
| Measure |
Maribavir 400 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Number of Participants With CMV Recurrence
|
7 participants
|
11 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 6 weeks after start of treatment, within 36 weeks of start of treatmentPopulation: The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.
Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time from first dose of study drug to first undetectable plasma CMV DNA within 6 weeks and at any time during the study, defined as the date of the first of at least 2 consecutive post-baseline, on-treatment undetectable results (\<200 copies/mL) separated by at least 5 days; as assessed by the central laboratory. The median values are Kaplan-Meier estimates.
Outcome measures
| Measure |
Maribavir 400 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Time to First Confirmed Undetectable Plasma CMV DNA Within 6 Weeks and at Any Time During The Study
Within 6 weeks, n = 40, 40, 38
|
24.0 days
Interval 15.0 to 31.0
|
28.0 days
Interval 15.0 to 36.0
|
22.0 days
Interval 15.0 to 28.0
|
|
Time to First Confirmed Undetectable Plasma CMV DNA Within 6 Weeks and at Any Time During The Study
Anytime during the study, n = 40, 40, 40
|
24.0 days
Interval 15.0 to 31.0
|
28.0 days
Interval 15.0 to 38.0
|
22.0 days
Interval 19.0 to 30.0
|
SECONDARY outcome
Timeframe: 36 weeksPopulation: The Intent-to-Treat Safety population, defined as all randomized participants who received at least 1 dose of study drug.
Blood samples were collected at the study sites, processed to plasma aliquots, and sent to the central laboratory for quantitative CMV DNA polymerase chain reaction (PCR) testing. Plasma samples were assayed for CMV concentration using a qualified PCR method. The time to event was defined as the time of the first of at least 2 consecutive samples, separated by at least 5 days, with detectable plasma CMV DNA after achievement of undetectable plasma CMV DNA in at least 2 consecutive samples, separated by at least 5 days, at any time after Day 1; as assessed by the central laboratory. Participants assessed for recurrence (n= 29, 27, 30) are the subset of the ITT-S who had at least 2 consecutive undetectable plasma CMV DNA results separated by at least 5 days, including early withdrawn qualified subjects. The median values are Kaplan-Meier estimates.
Outcome measures
| Measure |
Maribavir 400 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=40 Participants
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Time to CMV Recurrence
|
NA days
The median and 95% CIs were not estimable.
|
118.0 days
Interval 37.0 to
The upper 95% CI was not estimable.
|
161.0 days
Interval 92.0 to
The upper 95% CI was not estimable.
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visitPopulation: The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations
For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.
Outcome measures
| Measure |
Maribavir 400 mg Twice Daily
n=12 Participants
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=13 Participants
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=8 Participants
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Maximum Concentration (Cmax) of Maribavir
Visit 3, n = 12, 10, 8
|
18.5 ug/mL
Standard Deviation 7.39
|
35.1 ug/mL
Standard Deviation 12.0
|
45.1 ug/mL
Standard Deviation 21.2
|
|
Maximum Concentration (Cmax) of Maribavir
Visit 6, n = 8, 10, 6
|
17.8 ug/mL
Standard Deviation 8.36
|
25.0 ug/mL
Standard Deviation 9.69
|
35.6 ug/mL
Standard Deviation 25.8
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visitPopulation: The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.
For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.
Outcome measures
| Measure |
Maribavir 400 mg Twice Daily
n=12 Participants
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=13 Participants
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=8 Participants
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Time to Maximum Concentration (Tmax) of Maribavir
Visit 3, n = 12, 10, 8
|
3.56 hours
Standard Deviation 2.99
|
2.70 hours
Standard Deviation 2.89
|
2.81 hours
Standard Deviation 2.02
|
|
Time to Maximum Concentration (Tmax) of Maribavir
Visit 6, n = 8, 10, 6
|
1.66 hours
Standard Deviation 0.765
|
3.23 hours
Standard Deviation 2.28
|
3.12 hours
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visitPopulation: The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.
For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.
Outcome measures
| Measure |
Maribavir 400 mg Twice Daily
n=12 Participants
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=13 Participants
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=8 Participants
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Time of Last Non-Zero Concentration (Tlast) of Maribavir
Visit 3, n = 12, 10, 8
|
9.03 hours
Standard Deviation 2.55
|
8.26 hours
Standard Deviation 2.48
|
8.71 hours
Standard Deviation 1.45
|
|
Time of Last Non-Zero Concentration (Tlast) of Maribavir
Visit 6, n = 8, 10, 6
|
7.37 hours
Standard Deviation 3.70
|
7.99 hours
Standard Deviation 1.65
|
8.61 hours
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visitPopulation: The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.
For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.
Outcome measures
| Measure |
Maribavir 400 mg Twice Daily
n=12 Participants
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=13 Participants
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=8 Participants
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Area Under The Plasma Concentration Versus Time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast) of Maribavir
Visit 3, n = 12, 10, 8
|
100 h*ug/mL
Standard Deviation 50.4
|
179 h*ug/mL
Standard Deviation 69.6
|
264 h*ug/mL
Standard Deviation 147
|
|
Area Under The Plasma Concentration Versus Time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast) of Maribavir
Visit 6, n = 8, 10, 6
|
90.9 h*ug/mL
Standard Deviation 64.3
|
139 h*ug/mL
Standard Deviation 61.3
|
207 h*ug/mL
Standard Deviation 161
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 3, 4, 6, 8, and 12 hours post-dose on Day 8 and the Week 4 visitPopulation: The Pharmacokinetic Profile Population, defined as all participants in the ITT-S Population who had plasma samples drawn and tested for maribavir concentrations.
For the subset of participants who had pharmacokinetic (PK) profiling performed, non-compartmental PK analyses were used to determine Cmax, time to Cmax (tmax), time of last non-zero concentration (tlast), area under the plasma concentration versus time curve from the time of dosing to the last measurable concentration (AUClast), and half-life (t½). Values below the LLOQ post-baseline were replaced with a value of 0 ug/mL. Values below the LLOQ at baseline were replaced with zero as it was assumed that subjects had no levels of maribavir at baseline. At the designated timepoints, the PK sample was obtained 2-4 hours after the dose of study drug; for subjects who were inpatients, a pre-dose PK sample also was collected. These samples were not required at Day 8 and Week 4 for subjects who had PK profiles performed on those days.
Outcome measures
| Measure |
Maribavir 400 mg Twice Daily
n=12 Participants
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=13 Participants
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=8 Participants
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Half-Life (T½) of Maribavir
Visit 3, n = 6, 7, 3
|
5.56 hours
Standard Deviation 3.85
|
6.08 hours
Standard Deviation 3.51
|
7.77 hours
Standard Deviation 3.59
|
|
Half-Life (T½) of Maribavir
Visit 6, n = 5, 5, 3
|
4.32 hours
Standard Deviation 1.25
|
6.34 hours
Standard Deviation 1.41
|
5.33 hours
Standard Deviation 2.55
|
Adverse Events
Maribavir 400 mg Twice Daily
Serious events: 28 serious events
Other events: 40 other events
Deaths: 0 deaths
Maribavir 800 mg Twice Daily
Serious events: 27 serious events
Other events: 40 other events
Deaths: 0 deaths
Maribavir 1200 mg Twice Daily
Serious events: 26 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Maribavir 400 mg Twice Daily
n=40 participants at risk
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=40 participants at risk
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=40 participants at risk
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Haemolysis
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac tamponade
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Multi-organ failure
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Acute graft versus host disease
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Lung transplant rejection
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Adenovirus infection
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Appendicitis
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacterial sepsis
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchiolitis
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus gastroenteritis
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
15.0%
6/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Encephalitis viral
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Blood stem cell transplant failure
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Central nervous system haemorrhage
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute prerenal failure
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Jugular vein thrombosis
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Encephalitis cytomegalovirus
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex meningoencephalitis
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Parvovirus infection
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Post transplant lymphoproliferative disorder
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Jejunal ulcer
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Arteriovenous fistula site infection
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nocardiosis
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar damage
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Immunosuppresant drug level increased
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Maribavir 400 mg Twice Daily
n=40 participants at risk
Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 800 mg Twice Daily
n=40 participants at risk
Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
Maribavir 1200 mg Twice Daily
n=40 participants at risk
Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
|
|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
60.0%
24/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
62.5%
25/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
72.5%
29/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
35.0%
14/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
22.5%
9/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
30.0%
12/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
27.5%
11/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
30.0%
12/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
27.5%
11/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
20.0%
8/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
27.5%
11/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
25.0%
10/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
17.5%
7/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
25.0%
10/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
17.5%
7/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
17.5%
7/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
25.0%
10/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
27.5%
11/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
15.0%
6/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
22.5%
9/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
15.0%
6/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
17.5%
7/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.5%
7/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
15.0%
6/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
15.0%
6/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Immunosuppressant drug level increased
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
15.0%
6/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
20.0%
8/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridium difficile infection
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Acute graft versus host disease
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
12.5%
5/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Bacterial test positive
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Lung transplant rejection
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
BK virus infection
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Local swelling
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
10.0%
4/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Gait disturbance
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Eye disorders
Visual impairment
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
7.5%
3/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
2.5%
1/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Blood urea increased
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
General disorders
Swelling
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
5.0%
2/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
0.00%
0/40
Treatment emergent AEs are reported for the Intent-to-Treat Safety Population, defined as all randomized participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER