Trial Outcomes & Findings for Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients (NCT NCT00942305)
NCT ID: NCT00942305
Last Updated: 2021-07-16
Results Overview
The primary efficacy endpoint was a binomial outcome of failure to prevent cytomegalovirus (CMV) infection defined as CMV DNAemia \>200 copies/mL obtained at the time of the last treatment with study drug or diagnosis of CMV disease at some point during the treatment phase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
239 participants
Primary outcome timeframe
Randomization to Week 8 post-treatment (~19 weeks)
Results posted on
2021-07-16
Participant Flow
Note: While a total of 239 subjects were enrolled, 1 center was excluded from analysis due to concerns about investigator/site compliance with the study protocol. This center had enrolled 9 subjects: 5 subjects who received brincidofovir (BCV) in Cohort 1, 2 subjects who received placebo in Cohort 1, and 2 subjects who received BCV in Cohort 2.
Participant milestones
| Measure |
Cohort 1 BCV
40 mg brincidofovir (BCV) administered once weekly
|
Cohort 1 Placebo
Placebo administered once weekly (QW)
|
Cohort 2 BCV
100 mg brincidofovir (BCV) administered once weekly
|
Cohort 2 Placebo
Placebo administered once weekly (QW)
|
Cohort 3 BCV
200 mg brincidofovir (BCV) administered once weekly
|
Cohort 3 Placebo
Placebo administered once weekly (QW)
|
Cohort 4 BCV
200 mg brincidofovir (BCV) administered twice weekly (BIW)
Note: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose.
|
Cohort 4 Placebo
Placebo administered twice weekly (BIW)
|
Cohort 4a
100 mg brincidofovir (BCV) administered twice weekly (BIW)
|
Cohort 4a Placebo
Placebo administered twice weekly (BIW)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
10
|
29
|
10
|
39
|
14
|
30
|
10
|
50
|
17
|
|
Overall Study
COMPLETED
|
7
|
5
|
14
|
4
|
14
|
9
|
6
|
5
|
25
|
7
|
|
Overall Study
NOT COMPLETED
|
23
|
5
|
15
|
6
|
25
|
5
|
24
|
5
|
25
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of CMX001 to Prevent/Control Cytomegalovirus Infection in R+ Hematopoietic Stem Cell Transplant Recipients
Baseline characteristics by cohort
| Measure |
Cohort 1 BCV
n=25 Participants
40 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 1 Placebo
n=8 Participants
Placebo administered once weekly (QW)
|
Cohort 2 BCV
n=27 Participants
100 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 2 Placebo
n=10 Participants
Placebo administered once weekly (QW)
|
Cohort 3 BCV
n=39 Participants
200 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 3 Placebo
n=14 Participants
Placebo administered once weekly (QW)
|
Cohort 4 BCV
n=30 Participants
200 mg brincidofovir (BCV) administered twice weekly (BIW)
Note: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose.
|
Cohort 4 Placebo
n=10 Participants
Placebo administered twice weekly (BIW)
|
Cohort 4a BCV
n=50 Participants
100 mg brincidofovir (BCV) administered twice weekly (BIW)
|
Cohort 4a Placebo
n=17 Participants
Placebo administered twice weekly (BIW)
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 10.12 • n=7 Participants
|
51.7 years
STANDARD_DEVIATION 10.13 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 11.08 • n=4 Participants
|
49.5 years
STANDARD_DEVIATION 12.75 • n=21 Participants
|
47.9 years
STANDARD_DEVIATION 14.05 • n=8 Participants
|
50.4 years
STANDARD_DEVIATION 11.47 • n=8 Participants
|
52.2 years
STANDARD_DEVIATION 14.76 • n=24 Participants
|
48.8 years
STANDARD_DEVIATION 12.74 • n=42 Participants
|
46.1 years
STANDARD_DEVIATION 12.14 • n=42 Participants
|
50.7 years
STANDARD_DEVIATION 12.12 • n=42 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
98 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
132 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Randomization to Week 8 post-treatment (~19 weeks)Population: Modified Intent-to-Treat Population, which included all randomized subjects who took at least 1 dose of study treatment and who had at least 1 efficacy evaluation following baseline.
The primary efficacy endpoint was a binomial outcome of failure to prevent cytomegalovirus (CMV) infection defined as CMV DNAemia \>200 copies/mL obtained at the time of the last treatment with study drug or diagnosis of CMV disease at some point during the treatment phase.
Outcome measures
| Measure |
Cohort 1 BCV
n=25 Participants
40 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 1 Placebo
n=8 Participants
Placebo administered once weekly (QW)
|
Cohort 2 BCV
n=27 Participants
100 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 2 Placebo
n=10 Participants
Placebo administered once weekly (QW)
|
Cohort 3 BCV
n=39 Participants
200 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 3 Placebo
n=14 Participants
Placebo administered once weekly (QW)
|
Cohort 4 BCV
n=30 Participants
200 mg brincidofovir (BCV) administered twice weekly (BIW)
Note: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose.
|
Cohort 4 Placebo
n=10 Participants
Placebo administered twice weekly (BIW)
|
Cohort 4a BCV
n=50 Participants
100 mg brincidofovir (BCV) administered twice weekly (BIW)
|
Cohort 4a Placebo
n=17 Participants
Placebo administered twice weekly (BIW)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant CMV Infection
|
13 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
12 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
Adverse Events
Cohort 1 BCV
Serious events: 12 serious events
Other events: 25 other events
Deaths: 0 deaths
Cohort 1 Placebo
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 2 BCV
Serious events: 10 serious events
Other events: 27 other events
Deaths: 0 deaths
Cohort 2 Placebo
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort 3 BCV
Serious events: 19 serious events
Other events: 39 other events
Deaths: 0 deaths
Cohort 3 Placebo
Serious events: 6 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 4 BCV
Serious events: 21 serious events
Other events: 30 other events
Deaths: 0 deaths
Cohort 4 Placebo
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 4a BCV
Serious events: 30 serious events
Other events: 50 other events
Deaths: 0 deaths
Cohort 4a Placebo
Serious events: 8 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 BCV
n=25 participants at risk
40 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 1 Placebo
n=8 participants at risk
Placebo administered once weekly (QW)
|
Cohort 2 BCV
n=27 participants at risk
100 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 2 Placebo
n=10 participants at risk
Placebo administered once weekly (QW)
|
Cohort 3 BCV
n=39 participants at risk
200 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 3 Placebo
n=14 participants at risk
Placebo administered once weekly (QW)
|
Cohort 4 BCV
n=30 participants at risk
200 mg brincidofovir (BCV) administered twice weekly (BIW)
Note: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose.
|
Cohort 4 Placebo
n=10 participants at risk
Placebo administered twice weekly (BIW)
|
Cohort 4a BCV
n=50 participants at risk
100 mg brincidofovir (BCV) administered twice weekly (BIW)
|
Cohort 4a Placebo
n=17 participants at risk
Placebo administered twice weekly (BIW)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.0%
2/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
33.3%
10/30
|
0.00%
0/10
|
10.0%
5/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
6.7%
2/30
|
10.0%
1/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
General disorders
Chills
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
General disorders
Fatigue
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
General disorders
Multi-organ failure
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
General disorders
Pyrexia
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
20.0%
2/10
|
7.7%
3/39
|
0.00%
0/14
|
3.3%
1/30
|
20.0%
2/10
|
4.0%
2/50
|
11.8%
2/17
|
|
Hepatobiliary disorders
Cholecytitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Hepatobiliary disorders
Cholelithiasis
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
7.7%
3/39
|
0.00%
0/14
|
40.0%
12/30
|
0.00%
0/10
|
30.0%
15/50
|
11.8%
2/17
|
|
Infections and infestations
Acute graft versus host disease in intestine
|
4.0%
1/25
|
0.00%
0/8
|
7.4%
2/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Immune system disorders
Acute graft versus host disease in liver
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Immune system disorders
Acute graft versus host disease in skin
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Immune system disorders
Graft versus host disease
|
4.0%
1/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Appendicitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/25
|
12.5%
1/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
BK virus infection
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Cellulitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Citrobacter infection
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Cytomegalovirus gastroenteritis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Infections and infestations
Metapneumovirus infection
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Oral herpes
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Pneumonia
|
0.00%
0/25
|
0.00%
0/8
|
7.4%
2/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
8.0%
4/50
|
0.00%
0/17
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Sepsis
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Septic shock
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Infections and infestations
Serratia bacteraemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
3.3%
1/30
|
0.00%
0/10
|
8.0%
4/50
|
0.00%
0/17
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Viral haemorrhagic cystitis
|
4.0%
1/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Viral sinusitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Investigations
Bacteria stool identified
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Investigations
Liver function test abnormal
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Investigations
Weight decreased
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
14.3%
2/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Espstein-Barr virus associated lymphoproliferative disorder
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma recurrent
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Teratoma
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Nervous system disorders
Convulsion
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
Other adverse events
| Measure |
Cohort 1 BCV
n=25 participants at risk
40 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 1 Placebo
n=8 participants at risk
Placebo administered once weekly (QW)
|
Cohort 2 BCV
n=27 participants at risk
100 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 2 Placebo
n=10 participants at risk
Placebo administered once weekly (QW)
|
Cohort 3 BCV
n=39 participants at risk
200 mg brincidofovir (BCV) administered once weekly (QW)
|
Cohort 3 Placebo
n=14 participants at risk
Placebo administered once weekly (QW)
|
Cohort 4 BCV
n=30 participants at risk
200 mg brincidofovir (BCV) administered twice weekly (BIW)
Note: This dose was reduced to 200 mg BCV once weekly for ongoing subjects in this cohort following the recommendation of the Data and Safety Monitoring Board. No new subjects were enrolled into this cohort following the decision to reduce the dose.
|
Cohort 4 Placebo
n=10 participants at risk
Placebo administered twice weekly (BIW)
|
Cohort 4a BCV
n=50 participants at risk
100 mg brincidofovir (BCV) administered twice weekly (BIW)
|
Cohort 4a Placebo
n=17 participants at risk
Placebo administered twice weekly (BIW)
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Blood and lymphatic system disorders
Anaemia
|
4.0%
1/25
|
0.00%
0/8
|
7.4%
2/27
|
0.00%
0/10
|
5.1%
2/39
|
14.3%
2/14
|
6.7%
2/30
|
10.0%
1/10
|
4.0%
2/50
|
17.6%
3/17
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
8.0%
2/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
2.6%
1/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
10.0%
3/30
|
0.00%
0/10
|
4.0%
2/50
|
5.9%
1/17
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.0%
1/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.0%
2/25
|
0.00%
0/8
|
14.8%
4/27
|
10.0%
1/10
|
10.3%
4/39
|
0.00%
0/14
|
13.3%
4/30
|
20.0%
2/10
|
20.0%
10/50
|
23.5%
4/17
|
|
Blood and lymphatic system disorders
Pancytopenia
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
2.6%
1/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.0%
3/25
|
0.00%
0/8
|
11.1%
3/27
|
10.0%
1/10
|
0.00%
0/39
|
7.1%
1/14
|
16.7%
5/30
|
0.00%
0/10
|
14.0%
7/50
|
11.8%
2/17
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Cardiac disorders
Palpitations
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
20.0%
2/10
|
5.1%
2/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
4.0%
2/50
|
5.9%
1/17
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
14.3%
2/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Endocrine disorders
Adrenal insufficiency
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
11.8%
2/17
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Eye disorders
Dry eye
|
4.0%
1/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
6.7%
2/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Eye disorders
Eye pain
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Eye disorders
Eyelid margin crusting
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Eye disorders
Myodesopsia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Eye disorders
Vision blurred
|
4.0%
1/25
|
0.00%
0/8
|
7.4%
2/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
8.0%
4/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Abdominal distension
|
8.0%
2/25
|
0.00%
0/8
|
7.4%
2/27
|
20.0%
2/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Abdominal pain
|
16.0%
4/25
|
12.5%
1/8
|
7.4%
2/27
|
0.00%
0/10
|
12.8%
5/39
|
7.1%
1/14
|
36.7%
11/30
|
0.00%
0/10
|
26.0%
13/50
|
11.8%
2/17
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.0%
1/25
|
12.5%
1/8
|
7.4%
2/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
10.0%
3/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Cheilitis
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Constipation
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
5.1%
2/39
|
0.00%
0/14
|
10.0%
3/30
|
0.00%
0/10
|
4.0%
2/50
|
11.8%
2/17
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
3/25
|
25.0%
2/8
|
29.6%
8/27
|
40.0%
4/10
|
33.3%
13/39
|
28.6%
4/14
|
70.0%
21/30
|
20.0%
2/10
|
52.0%
26/50
|
23.5%
4/17
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
20.0%
2/10
|
8.0%
4/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Dyspepsia
|
12.0%
3/25
|
12.5%
1/8
|
7.4%
2/27
|
0.00%
0/10
|
10.3%
4/39
|
14.3%
2/14
|
3.3%
1/30
|
0.00%
0/10
|
8.0%
4/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
10.0%
3/30
|
0.00%
0/10
|
6.0%
3/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.0%
2/25
|
0.00%
0/8
|
14.8%
4/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Nausea
|
24.0%
6/25
|
12.5%
1/8
|
18.5%
5/27
|
10.0%
1/10
|
28.2%
11/39
|
28.6%
4/14
|
36.7%
11/30
|
30.0%
3/10
|
34.0%
17/50
|
17.6%
3/17
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Oral disorder
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Stomatitis
|
4.0%
1/25
|
0.00%
0/8
|
3.7%
1/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25
|
12.5%
1/8
|
22.2%
6/27
|
20.0%
2/10
|
15.4%
6/39
|
28.6%
4/14
|
26.7%
8/30
|
10.0%
1/10
|
44.0%
22/50
|
17.6%
3/17
|
|
General disorders
Adverse drug reaction
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
General disorders
Asthenia
|
12.0%
3/25
|
0.00%
0/8
|
3.7%
1/27
|
10.0%
1/10
|
7.7%
3/39
|
7.1%
1/14
|
6.7%
2/30
|
10.0%
1/10
|
2.0%
1/50
|
11.8%
2/17
|
|
General disorders
Chills
|
4.0%
1/25
|
12.5%
1/8
|
0.00%
0/27
|
10.0%
1/10
|
7.7%
3/39
|
21.4%
3/14
|
0.00%
0/30
|
10.0%
1/10
|
4.0%
2/50
|
0.00%
0/17
|
|
General disorders
Early satiety
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
General disorders
Face oedema
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
General disorders
Fatigue
|
4.0%
1/25
|
25.0%
2/8
|
11.1%
3/27
|
0.00%
0/10
|
12.8%
5/39
|
21.4%
3/14
|
0.00%
0/30
|
10.0%
1/10
|
18.0%
9/50
|
17.6%
3/17
|
|
General disorders
Generalised oedema
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
10.0%
3/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
General disorders
Hypothermia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
3.3%
1/30
|
10.0%
1/10
|
4.0%
2/50
|
0.00%
0/17
|
|
General disorders
Oedema
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
General disorders
Oedema peripheral
|
12.0%
3/25
|
0.00%
0/8
|
18.5%
5/27
|
10.0%
1/10
|
7.7%
3/39
|
14.3%
2/14
|
10.0%
3/30
|
20.0%
2/10
|
16.0%
8/50
|
5.9%
1/17
|
|
General disorders
Pain
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
4.0%
2/50
|
5.9%
1/17
|
|
General disorders
Pyrexia
|
4.0%
1/25
|
12.5%
1/8
|
3.7%
1/27
|
30.0%
3/10
|
17.9%
7/39
|
7.1%
1/14
|
6.7%
2/30
|
20.0%
2/10
|
20.0%
10/50
|
23.5%
4/17
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
7.7%
3/39
|
0.00%
0/14
|
16.7%
5/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
10.3%
4/39
|
0.00%
0/14
|
80.0%
24/30
|
20.0%
2/10
|
64.0%
32/50
|
35.3%
6/17
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
8.0%
2/25
|
0.00%
0/8
|
18.5%
5/27
|
10.0%
1/10
|
15.4%
6/39
|
14.3%
2/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Immune system disorders
Acute graft versus host disease in skin
|
16.0%
4/25
|
25.0%
2/8
|
11.1%
3/27
|
30.0%
3/10
|
17.9%
7/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Immune system disorders
Graft versus host disease
|
8.0%
2/25
|
12.5%
1/8
|
7.4%
2/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
7.1%
1/14
|
6.7%
2/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Aspergillosis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/25
|
12.5%
1/8
|
7.4%
2/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Infections and infestations
BK virus infection
|
4.0%
1/25
|
0.00%
0/8
|
14.8%
4/27
|
10.0%
1/10
|
7.7%
3/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Infections and infestations
Candidiasis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
10.0%
1/10
|
7.7%
3/39
|
0.00%
0/14
|
3.3%
1/30
|
10.0%
1/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.00%
0/25
|
12.5%
1/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/25
|
0.00%
0/8
|
7.4%
2/27
|
20.0%
2/10
|
10.3%
4/39
|
14.3%
2/14
|
6.7%
2/30
|
30.0%
3/10
|
4.0%
2/50
|
5.9%
1/17
|
|
Infections and infestations
Cytomegalovirus viraemia
|
40.0%
10/25
|
25.0%
2/8
|
14.8%
4/27
|
20.0%
2/10
|
17.9%
7/39
|
21.4%
3/14
|
16.7%
5/30
|
0.00%
0/10
|
12.0%
6/50
|
23.5%
4/17
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
0.00%
0/50
|
11.8%
2/17
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Folliculitis
|
0.00%
0/25
|
0.00%
0/8
|
7.4%
2/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
10.0%
1/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
12.0%
6/50
|
5.9%
1/17
|
|
Infections and infestations
Otitis media
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Infections and infestations
Pneumonia
|
4.0%
1/25
|
0.00%
0/8
|
7.4%
2/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
10.0%
5/50
|
0.00%
0/17
|
|
Infections and infestations
Proctitis herpes
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/25
|
12.5%
1/8
|
3.7%
1/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
3.3%
1/30
|
0.00%
0/10
|
12.0%
6/50
|
0.00%
0/17
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/25
|
0.00%
0/8
|
7.4%
2/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
10.0%
1/10
|
2.6%
1/39
|
0.00%
0/14
|
6.7%
2/30
|
10.0%
1/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Infections and infestations
Viral haemorrhagic cystitis
|
8.0%
2/25
|
12.5%
1/8
|
3.7%
1/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Ear abrasion
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/25
|
12.5%
1/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Injury, poisoning and procedural complications
Fall
|
8.0%
2/25
|
0.00%
0/8
|
3.7%
1/27
|
10.0%
1/10
|
2.6%
1/39
|
7.1%
1/14
|
3.3%
1/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Investigations
Alanine aminotransferase increased
|
8.0%
2/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
33.3%
10/30
|
0.00%
0/10
|
18.0%
9/50
|
5.9%
1/17
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
1/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
23.3%
7/30
|
0.00%
0/10
|
10.0%
5/50
|
5.9%
1/17
|
|
Investigations
Blood alkaline phosphatase increased
|
4.0%
1/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
10.0%
1/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Investigations
Blood creatinine increased
|
0.00%
0/25
|
0.00%
0/8
|
18.5%
5/27
|
0.00%
0/10
|
7.7%
3/39
|
14.3%
2/14
|
6.7%
2/30
|
0.00%
0/10
|
14.0%
7/50
|
5.9%
1/17
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
10.0%
3/30
|
0.00%
0/10
|
8.0%
4/50
|
0.00%
0/17
|
|
Investigations
Blood urea increased
|
4.0%
1/25
|
0.00%
0/8
|
7.4%
2/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Investigations
Blood urine present
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Investigations
Cytomegalovirus test positive
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Investigations
Echocardiogram abnormal
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
10.0%
3/30
|
10.0%
1/10
|
8.0%
4/50
|
0.00%
0/17
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
7.7%
3/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
5.9%
1/17
|
|
Investigations
Immunosuppressant drug level increased
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Investigations
Liver function test abnormal
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
5.1%
2/39
|
7.1%
1/14
|
10.0%
3/30
|
0.00%
0/10
|
4.0%
2/50
|
5.9%
1/17
|
|
Investigations
Neutrophil count decreased
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Investigations
Platelet count decreased
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
7.7%
3/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Investigations
Protein total increased
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Investigations
Protein urine present
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Investigations
Transaminases increased
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
8.0%
4/50
|
0.00%
0/17
|
|
Investigations
Weight decreased
|
12.0%
3/25
|
0.00%
0/8
|
14.8%
4/27
|
0.00%
0/10
|
0.00%
0/39
|
21.4%
3/14
|
3.3%
1/30
|
20.0%
2/10
|
12.0%
6/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.0%
4/25
|
12.5%
1/8
|
18.5%
5/27
|
10.0%
1/10
|
7.7%
3/39
|
7.1%
1/14
|
16.7%
5/30
|
20.0%
2/10
|
18.0%
9/50
|
11.8%
2/17
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/25
|
12.5%
1/8
|
7.4%
2/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
3.3%
1/30
|
10.0%
1/10
|
8.0%
4/50
|
11.8%
2/17
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
7.1%
1/14
|
6.7%
2/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.0%
1/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
26.7%
8/30
|
0.00%
0/10
|
18.0%
9/50
|
17.6%
3/17
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.0%
1/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
10.0%
3/30
|
0.00%
0/10
|
6.0%
3/50
|
5.9%
1/17
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.0%
2/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
10.0%
3/30
|
10.0%
1/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.0%
4/25
|
0.00%
0/8
|
7.4%
2/27
|
10.0%
1/10
|
12.8%
5/39
|
7.1%
1/14
|
16.7%
5/30
|
20.0%
2/10
|
16.0%
8/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.0%
3/25
|
0.00%
0/8
|
11.1%
3/27
|
10.0%
1/10
|
5.1%
2/39
|
14.3%
2/14
|
3.3%
1/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.0%
3/25
|
12.5%
1/8
|
3.7%
1/27
|
0.00%
0/10
|
17.9%
7/39
|
7.1%
1/14
|
6.7%
2/30
|
10.0%
1/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
5.1%
2/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
8.0%
4/50
|
5.9%
1/17
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
10.0%
3/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25
|
0.00%
0/8
|
11.1%
3/27
|
10.0%
1/10
|
2.6%
1/39
|
7.1%
1/14
|
3.3%
1/30
|
0.00%
0/10
|
6.0%
3/50
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/25
|
0.00%
0/8
|
7.4%
2/27
|
10.0%
1/10
|
5.1%
2/39
|
0.00%
0/14
|
10.0%
3/30
|
0.00%
0/10
|
8.0%
4/50
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
11.8%
2/17
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
1/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
8.0%
4/50
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.0%
1/25
|
0.00%
0/8
|
7.4%
2/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
7.1%
1/14
|
6.7%
2/30
|
0.00%
0/10
|
4.0%
2/50
|
5.9%
1/17
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
7.7%
3/39
|
21.4%
3/14
|
3.3%
1/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia recurrent
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
12.0%
3/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
14.3%
2/14
|
0.00%
0/30
|
0.00%
0/10
|
6.0%
3/50
|
5.9%
1/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Nervous system disorders
Convulsion
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
2.6%
1/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25
|
12.5%
1/8
|
7.4%
2/27
|
0.00%
0/10
|
7.7%
3/39
|
14.3%
2/14
|
10.0%
3/30
|
0.00%
0/10
|
8.0%
4/50
|
0.00%
0/17
|
|
Nervous system disorders
Dysgeusia
|
4.0%
1/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
5.1%
2/39
|
7.1%
1/14
|
10.0%
3/30
|
0.00%
0/10
|
8.0%
4/50
|
5.9%
1/17
|
|
Nervous system disorders
Headache
|
0.00%
0/25
|
12.5%
1/8
|
11.1%
3/27
|
0.00%
0/10
|
7.7%
3/39
|
14.3%
2/14
|
13.3%
4/30
|
10.0%
1/10
|
6.0%
3/50
|
17.6%
3/17
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Nervous system disorders
Peropheral sensory neuropathy
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Nervous system disorders
Tremor
|
12.0%
3/25
|
0.00%
0/8
|
11.1%
3/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
6.7%
2/30
|
10.0%
1/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/25
|
0.00%
0/8
|
11.1%
3/27
|
20.0%
2/10
|
7.7%
3/39
|
7.1%
1/14
|
6.7%
2/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Psychiatric disorders
Confusional state
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Psychiatric disorders
Depression
|
4.0%
1/25
|
12.5%
1/8
|
7.4%
2/27
|
0.00%
0/10
|
7.7%
3/39
|
0.00%
0/14
|
10.0%
3/30
|
20.0%
2/10
|
8.0%
4/50
|
5.9%
1/17
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25
|
0.00%
0/8
|
7.4%
2/27
|
0.00%
0/10
|
12.8%
5/39
|
7.1%
1/14
|
6.7%
2/30
|
0.00%
0/10
|
18.0%
9/50
|
0.00%
0/17
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Renal and urinary disorders
Acute prerenal failure
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Renal and urinary disorders
Dysuria
|
4.0%
1/25
|
25.0%
2/8
|
11.1%
3/27
|
20.0%
2/10
|
7.7%
3/39
|
7.1%
1/14
|
3.3%
1/30
|
10.0%
1/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/25
|
12.5%
1/8
|
3.7%
1/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Renal and urinary disorders
Renal failure
|
4.0%
1/25
|
12.5%
1/8
|
7.4%
2/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Renal and urinary disorders
Renal failure acute
|
8.0%
2/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
10.0%
3/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
7.1%
1/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25
|
0.00%
0/8
|
7.4%
2/27
|
20.0%
2/10
|
5.1%
2/39
|
7.1%
1/14
|
6.7%
2/30
|
0.00%
0/10
|
8.0%
4/50
|
11.8%
2/17
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
1/25
|
12.5%
1/8
|
3.7%
1/27
|
20.0%
2/10
|
7.7%
3/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
6.0%
3/50
|
5.9%
1/17
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
4.0%
2/50
|
11.8%
2/17
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/25
|
0.00%
0/8
|
7.4%
2/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
11.8%
2/17
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
20.0%
2/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
8.0%
4/50
|
11.8%
2/17
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.0%
2/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
10.3%
4/39
|
7.1%
1/14
|
0.00%
0/30
|
20.0%
2/10
|
8.0%
4/50
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.0%
3/25
|
25.0%
2/8
|
14.8%
4/27
|
20.0%
2/10
|
10.3%
4/39
|
7.1%
1/14
|
3.3%
1/30
|
0.00%
0/10
|
10.0%
5/50
|
17.6%
3/17
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/25
|
12.5%
1/8
|
0.00%
0/27
|
0.00%
0/10
|
7.7%
3/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
11.8%
2/17
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
6.7%
2/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Surgical and medical procedures
Sinus operation
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Vascular disorders
Deep vein thrombosis
|
4.0%
1/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Vascular disorders
Haematoma
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Vascular disorders
Hypertension
|
0.00%
0/25
|
12.5%
1/8
|
7.4%
2/27
|
10.0%
1/10
|
10.3%
4/39
|
14.3%
2/14
|
20.0%
6/30
|
10.0%
1/10
|
12.0%
6/50
|
17.6%
3/17
|
|
Vascular disorders
Hypotension
|
8.0%
2/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
10.0%
3/30
|
20.0%
2/10
|
4.0%
2/50
|
0.00%
0/17
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/25
|
0.00%
0/8
|
3.7%
1/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
6.0%
3/50
|
0.00%
0/17
|
|
Gastrointestinal disorders
Cholitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
5.9%
1/17
|
|
General disorders
Multi-organ failure
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Immune system disorders
Acute graft versus host disease in liver
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Cellulitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
7.1%
1/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Infections and infestations
Septic shock
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Infections and infestations
Serratia bacteraemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
2.6%
1/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
5.9%
1/17
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
2.0%
1/50
|
0.00%
0/17
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
3.3%
1/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr virus associated lymphoproliferative disorder
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
10.0%
1/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
5.1%
2/39
|
0.00%
0/14
|
0.00%
0/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
6.7%
2/30
|
0.00%
0/10
|
0.00%
0/50
|
0.00%
0/17
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/25
|
0.00%
0/8
|
0.00%
0/27
|
0.00%
0/10
|
0.00%
0/39
|
0.00%
0/14
|
0.00%
0/30
|
10.0%
1/10
|
0.00%
0/50
|
0.00%
0/17
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Within 18 months after the end of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given opportunity to review and comment. Institution publication may be delayed up to an additional 45 days to allow Sponsor to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER