Trial Outcomes & Findings for A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients (NCT NCT04294472)
NCT ID: NCT04294472
Last Updated: 2023-06-07
Results Overview
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Study Week 1 - Study Week 36
Results posted on
2023-06-07
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: 5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses
|
Active Arm (Cohort 1)
MAU868 1350 mg every 28 days for a total of 4 doses
|
Active Arm (Cohort 2)
MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
11
|
11
|
|
Overall Study
COMPLETED
|
8
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo: 5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses
|
Active Arm (Cohort 1)
MAU868 1350 mg every 28 days for a total of 4 doses
|
Active Arm (Cohort 2)
MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Randomized but not treated
|
0
|
1
|
1
|
Baseline Characteristics
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Placebo: 5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses
|
Active Arm (Cohort 1)
n=10 Participants
MAU868 1350 mg every 28 days for a total of 4 doses
|
Active Arm (Cohort 2)
n=10 Participants
MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 16.85 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 13.52 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 8.50 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 12.97 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
eGFR (CK-EPI)(mL/min/ 1.73m^2)
|
59.5 mL/min/ 1.73m^2
STANDARD_DEVIATION 21.23 • n=5 Participants
|
54.1 mL/min/ 1.73m^2
STANDARD_DEVIATION 22.93 • n=7 Participants
|
51.1 mL/min/ 1.73m^2
STANDARD_DEVIATION 11.53 • n=5 Participants
|
54.6 mL/min/ 1.73m^2
STANDARD_DEVIATION 18.66 • n=4 Participants
|
|
Time from Kidney Transplant (days)
|
174.6 Days
STANDARD_DEVIATION 82.57 • n=5 Participants
|
175.6 Days
STANDARD_DEVIATION 93.53 • n=7 Participants
|
143.5 Days
STANDARD_DEVIATION 89.72 • n=5 Participants
|
163.9 Days
STANDARD_DEVIATION 87.21 • n=4 Participants
|
|
Baseline Plasma Viral Load (copies/mL) based on central lab
|
315100.0 copies/mL
STANDARD_DEVIATION 620601.58 • n=5 Participants
|
85100.0 copies/mL
STANDARD_DEVIATION 152159.91 • n=7 Participants
|
24690.0 copies/mL
STANDARD_DEVIATION 36203.73 • n=5 Participants
|
129239.3 copies/mL
STANDARD_DEVIATION 350731.32 • n=4 Participants
|
|
Duration of BK Viremia (days)
|
58.4 Days
STANDARD_DEVIATION 23.11 • n=5 Participants
|
56.6 Days
STANDARD_DEVIATION 39.33 • n=7 Participants
|
41.9 Days
STANDARD_DEVIATION 23.74 • n=5 Participants
|
51.9 Days
STANDARD_DEVIATION 29.99 • n=4 Participants
|
PRIMARY outcome
Timeframe: Study Week 1 - Study Week 36The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo: 5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses
|
Active Arm (Cohort 1)
n=10 Participants
MAU868 1350 mg every 28 days for a total of 4 doses
|
Active Arm (Cohort 2)
n=10 Participants
MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses
|
|---|---|---|---|
|
Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log
|
19.61 Weeks
Standard Deviation 11.75
|
10.80 Weeks
Standard Deviation 11.50
|
18.25 Weeks
Standard Deviation 16.28
|
PRIMARY outcome
Timeframe: Study Week 1 - Study Week 36The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
Outcome measures
| Measure |
Placebo
n=8 Participants
Placebo: 5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses
|
Active Arm (Cohort 1)
n=10 Participants
MAU868 1350 mg every 28 days for a total of 4 doses
|
Active Arm (Cohort 2)
n=10 Participants
MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses
|
|---|---|---|---|
|
Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)
|
NA Weeks
Standard Deviation NA
No subjects in placebo group achieved BKV plasma viral load to less than lower limit of quantification
|
16.79 Weeks
Standard Deviation 13.57
|
8.18 Weeks
Standard Deviation 6.46
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Active Arm (Cohort 1)
Serious events: 6 serious events
Other events: 9 other events
Deaths: 1 deaths
Active Arm (Cohort 2)
Serious events: 6 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Placebo
n=8 participants at risk
Placebo: 5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses
|
Active Arm (Cohort 1)
n=10 participants at risk
MAU868 1350 mg every 28 days for a total of 4 doses
|
Active Arm (Cohort 2)
n=10 participants at risk
MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
General disorders
Hernia
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Oesophageal candidiasis
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Renal graft infection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Investigations
Transaminases increased
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
20.0%
2/10 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Placebo: 5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses
|
Active Arm (Cohort 1)
n=10 participants at risk
MAU868 1350 mg every 28 days for a total of 4 doses
|
Active Arm (Cohort 2)
n=10 participants at risk
MAU868 6750 once and 1350 mg every 28 days for a total of 4 doses
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
2/8 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
1/8 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
20.0%
2/10 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
General disorders
Cyst
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
General disorders
Infusion site extravasation
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
General disorders
Injection site swelling
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
General disorders
Oedema peripheral
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
General disorders
Pain
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Immune system disorders
Chronic allograft nephropathy
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Immune system disorders
Kidney transplant rejection
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
BK virus infection
|
25.0%
2/8 • Number of events 3 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Clostridium difficile infection
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Eye infection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Helicobacter infection
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Herpes zoster
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
20.0%
2/10 • Number of events 3 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Infections and infestations
Urinary tract infection bacterial
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
12.5%
1/8 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 5 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Investigations
Blood creatine phosphokinase increased
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Investigations
Blood creatinine increased
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
30.0%
3/10 • Number of events 3 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Investigations
Platelet count decreased
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Metabolism and nutrition disorders
Gout
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
20.0%
2/10 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Renal and urinary disorders
Chronic kidney disease
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 2 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
12.5%
1/8 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Vascular disorders
Haematoma
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Vascular disorders
Hypertension
|
37.5%
3/8 • Number of events 3 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 3 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/8 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
10.0%
1/10 • Number of events 1 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
0.00%
0/10 • Study Week 1 - Study Week 36
The Participant Flow module included 30 participants randomized; two subjects randomized but not treated were identified, leaving 28 randomized and treated subjects in subsequent modified intent-to-treat analyses. The Total Number of Participants at Risk was based on 28 randomized and treated participants.
|
Additional Information
Isabel Gorham, Director of Clinical Operations
Vera Therapeutics Inc.
Phone: (910)200-0532
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60