Trial Outcomes & Findings for An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers (NCT NCT03994601)
NCT ID: NCT03994601
Last Updated: 2026-01-20
Results Overview
Safety releated events for Cohorts 1A, 1B and 2B.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
219 participants
Primary outcome timeframe
approximately 6 months
Results posted on
2026-01-20
Participant Flow
Participant milestones
| Measure |
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
|
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
|
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
|
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
39
|
34
|
12
|
4
|
4
|
5
|
6
|
5
|
5
|
9
|
40
|
3
|
47
|
|
Overall Study
Crossing Over
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
39
|
33
|
12
|
4
|
4
|
5
|
6
|
5
|
5
|
9
|
40
|
3
|
47
|
Reasons for withdrawal
| Measure |
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 1
BMS-986288 BMS 20mg Q4W
|
Treatment 1A: Cohort 2
BMS-986288 40mg Q4W
|
Treatment 1A: Cohort 3
BMS-986288 80mg Q4W
|
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
7
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
3
|
|
Overall Study
Death
|
4
|
1
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
5
|
|
Overall Study
Other Reasons
|
3
|
4
|
2
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
4
|
0
|
4
|
|
Overall Study
Disease Progression
|
20
|
24
|
7
|
3
|
3
|
4
|
6
|
3
|
5
|
7
|
25
|
1
|
24
|
|
Overall Study
Study Drug Toxicity
|
3
|
3
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
3
|
0
|
0
|
|
Overall Study
AE Unrelated to Study Drug
|
5
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
4
|
|
Overall Study
Request to Discontinue
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
Baseline characteristics by cohort
| Measure |
Treatment 1A: Cohort 1
n=4 Participants
BMS-986288 BMS 20mg Q4W
|
Treatment 1A: Cohort 2
n=4 Participants
BMS-986288 40mg Q4W
|
Treatment 1A: Cohort 3
n=5 Participants
BMS-986288 80mg Q4W
|
Treatment 1A: Cohort 4
n=6 Participants
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=5 Participants
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=5 Participants
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=9 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=40 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 Participants
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=47 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=39 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 1
n=34 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=12 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Total
n=213 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.8 Years
STANDARD_DEVIATION 18.10 • n=37 Participants
|
61.3 Years
STANDARD_DEVIATION 7.46 • n=44 Participants
|
63.4 Years
STANDARD_DEVIATION 9.37 • n=40 Participants
|
65.3 Years
STANDARD_DEVIATION 8.71 • n=121 Participants
|
58.8 Years
STANDARD_DEVIATION 5.40 • n=84 Participants
|
54.8 Years
STANDARD_DEVIATION 13.59 • n=82 Participants
|
66.2 Years
STANDARD_DEVIATION 10.76 • n=6 Participants
|
59.6 Years
STANDARD_DEVIATION 11.63 • n=4 Participants
|
69.7 Years
STANDARD_DEVIATION 6.66 • n=33 Participants
|
63.3 Years
STANDARD_DEVIATION 9.44 • n=6 Participants
|
64.7 Years
STANDARD_DEVIATION 8.09 • n=6 Participants
|
61.2 Years
STANDARD_DEVIATION 11.43 • n=9 Participants
|
59.4 Years
STANDARD_DEVIATION 8.45 • n=9 Participants
|
61.9 Years
STANDARD_DEVIATION 10.54 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=37 Participants
|
3 Participants
n=44 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=121 Participants
|
2 Participants
n=84 Participants
|
2 Participants
n=82 Participants
|
4 Participants
n=6 Participants
|
17 Participants
n=4 Participants
|
2 Participants
n=33 Participants
|
14 Participants
n=6 Participants
|
11 Participants
n=6 Participants
|
14 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
79 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
3 Participants
n=40 Participants
|
5 Participants
n=121 Participants
|
3 Participants
n=84 Participants
|
3 Participants
n=82 Participants
|
5 Participants
n=6 Participants
|
23 Participants
n=4 Participants
|
1 Participants
n=33 Participants
|
33 Participants
n=6 Participants
|
28 Participants
n=6 Participants
|
20 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
134 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=121 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=33 Participants
|
6 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
28 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=37 Participants
|
4 Participants
n=44 Participants
|
4 Participants
n=40 Participants
|
5 Participants
n=121 Participants
|
4 Participants
n=84 Participants
|
5 Participants
n=82 Participants
|
7 Participants
n=6 Participants
|
28 Participants
n=4 Participants
|
1 Participants
n=33 Participants
|
8 Participants
n=6 Participants
|
17 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
100 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
1 Participants
n=84 Participants
|
0 Participants
n=82 Participants
|
2 Participants
n=6 Participants
|
9 Participants
n=4 Participants
|
1 Participants
n=33 Participants
|
33 Participants
n=6 Participants
|
18 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
85 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
3 Participants
n=40 Participants
|
5 Participants
n=121 Participants
|
5 Participants
n=84 Participants
|
5 Participants
n=82 Participants
|
8 Participants
n=6 Participants
|
33 Participants
n=4 Participants
|
2 Participants
n=33 Participants
|
44 Participants
n=6 Participants
|
38 Participants
n=6 Participants
|
33 Participants
n=9 Participants
|
11 Participants
n=9 Participants
|
191 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=121 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=33 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=37 Participants
|
2 Participants
n=44 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
7 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=121 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=6 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=33 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=9 Participants
|
10 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: approximately 6 monthsPopulation: Safety Population
Safety releated events for Cohorts 1A, 1B and 2B.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=5 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=4 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
n=6 Participants
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=5 Participants
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=5 Participants
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=9 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=40 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 Participants
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=47 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=39 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety Related Events for Cohorts 1A, 1B and 2B.
SAEs
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
29 Participants
|
3 Participants
|
34 Participants
|
30 Participants
|
|
Safety Related Events for Cohorts 1A, 1B and 2B.
AEs Leading to Discontinuation
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
12 Participants
|
2 Participants
|
14 Participants
|
15 Participants
|
|
Safety Related Events for Cohorts 1A, 1B and 2B.
Deaths
|
5 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
26 Participants
|
2 Participants
|
34 Participants
|
30 Participants
|
|
Safety Related Events for Cohorts 1A, 1B and 2B.
AEs
|
5 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
40 Participants
|
3 Participants
|
47 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: approximately 5 weeksPopulation: As Per Protocol, DLT Evaluable Participants in 1A, 1B and 2B.
A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=3 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=3 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
n=5 Participants
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=4 Participants
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=2 Participants
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=6 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=19 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 Participants
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=5 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicities Cohorts 1A, 1B and 2B.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: approximately 2.15 MonthsPopulation: Safety Population
The percentage of all treated participants whose BOR is either CR or PR by BICR per RECIST v1.1.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=34 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=12 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate by BICR in Cohort 2C
|
0 Percentage or Participants
Interval 0.0 to 60.2
|
0 Percentage or Participants
Interval 0.0 to 10.3
|
0 Percentage or Participants
Interval 0.0 to 26.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 2.15 MonthsPopulation: All Treated Participants in Cohort 1A, 1B and 2B
The percentage of all treated participants whose BOR is either CR or PR by Investigator per RECIST v1.1.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=5 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=4 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
n=6 Participants
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=5 Participants
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=5 Participants
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=9 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=40 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 Participants
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=47 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=39 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate in Cohorts 1A, 1B and 2B
|
20.0 Percentage of Participants
Interval 0.5 to 71.6
|
0 Percentage of Participants
Interval 0.0 to 60.2
|
25.0 Percentage of Participants
Interval 0.6 to 80.6
|
0 Percentage of Participants
Interval 0.0 to 45.9
|
0 Percentage of Participants
Interval 0.0 to 52.2
|
0 Percentage of Participants
Interval 0.0 to 52.2
|
22.2 Percentage of Participants
Interval 2.8 to 60.0
|
5.0 Percentage of Participants
Interval 0.6 to 16.9
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
6.4 Percentage of Participants
Interval 1.3 to 17.5
|
7.7 Percentage of Participants
Interval 1.6 to 20.9
|
SECONDARY outcome
Timeframe: approximately 2.15 MonthsPopulation: All Treated Participants in Cohort 1A, 1B and 2B who achievied CR or PR
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by Investigator (per RECIST 1.1), or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=1 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=1 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=2 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=2 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=3 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=3 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response in Cohorts 1A, 1B and 2B
|
5.59 months
insufficient number of participants with events to calculate via KM methodology
|
—
|
5.68 months
insufficient number of participants with events to calculate via KM methodology
|
—
|
—
|
—
|
NA months
Interval 3.12 to
insufficient number of participants with events to calculate via KM methodology
|
NA months
insufficient number of participants with events to calculate via KM methodology
|
—
|
NA months
Interval 2.73 to
insufficient number of participants with events to calculate via KM methodology
|
7.16 months
Interval 5.91 to
insufficient number of participants with events to calculate via KM methodology
|
SECONDARY outcome
Timeframe: approximately 2.15 MonthsPopulation: All Treated Participants in Cohort 1A, 1B and 2B who achievied CR or PR
Time to response (TTR) assessed by investigator is defined as the time between the date of randomization and the first confirmed documented response (CR or PR) per RECIST 1.1 criteria.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=1 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=1 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=2 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=2 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=3 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=3 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response in Cohorts 1A, 1B and 2B
|
1.87 months
Standard Deviation NA
insufficient number of participants to calculate SD
|
—
|
1.64 months
Standard Deviation NA
insufficient number of participants to calculate SD
|
—
|
—
|
—
|
4.78 months
Standard Deviation 2.21
|
2.56 months
Standard Deviation 1.30
|
—
|
6.14 months
Standard Deviation 2.19
|
3.76 months
Standard Deviation 3.45
|
SECONDARY outcome
Timeframe: approximately 2.15 MonthsPopulation: All Treated Participants in Cohort 1A, 1B and 2B
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=5 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=4 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
n=6 Participants
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=5 Participants
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=5 Participants
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=9 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=40 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 Participants
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=47 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=39 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival in Cohorts 1A, 1B and 2B
|
1.68 Months
Interval 0.92 to
insufficient number of participants with events to calculate via KM methodology
|
1.05 Months
Interval 0.95 to
insufficient number of participants with events to calculate via KM methodology
|
1.49 Months
Interval 1.25 to
insufficient number of participants with events to calculate via KM methodology
|
4.65 Months
Interval 0.49 to
insufficient number of participants with events to calculate via KM methodology
|
1.81 Months
Interval 1.18 to
insufficient number of participants with events to calculate via KM methodology
|
1.15 Months
Interval 0.56 to
insufficient number of participants with events to calculate via KM methodology
|
1.76 Months
Interval 0.79 to 9.43
|
1.91 Months
Interval 1.75 to 2.46
|
1.71 Months
Interval 1.28 to
insufficient number of participants with events to calculate via KM methodology
|
2.63 Months
Interval 1.87 to 3.71
|
2.40 Months
Interval 1.91 to 3.78
|
SECONDARY outcome
Timeframe: approximately 2.5 MonthsPopulation: All Treated Participants in Cohort 2C who achievied CR or PR
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by BICR (per RECIST 1.1), or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: approximately 2.5 MonthsPopulation: Safety Population
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by BICR or death due to any cause, whichever is earlier.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=34 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=12 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
PFS by BICR in Cohort 2C
|
2.89 Months
Interval 1.87 to
insufficient number of participants with events to calculate via KM methodology
|
2.10 Months
Interval 1.94 to 3.12
|
4.37 Months
Interval 1.74 to
insufficient number of participants with events to calculate via KM methodology
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 2.5 MonthsPopulation: Safety Population
OS is defined as the time from randomization to the time of death due to any cause.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=34 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=12 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival in Cohort 2C
|
NA Months
Interval 6.37 to
insufficient number of participants with events to calculate via KM methodology
|
NA Months
Interval 4.67 to
insufficient number of participants with events to calculate via KM methodology
|
6.67 Months
Interval 4.37 to
insufficient number of participants with events to calculate via KM methodology
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 2.5 MonthsPopulation: Safety Population
The percentage of all treated participants whose BOR is either CR or PR by Investigator per RECIST v1.1.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=34 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=12 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate by Investigator in Cohort 2C
|
0 Percentage or Participants
Interval 0.0 to 60.2
|
0 Percentage or Participants
Interval 0.0 to 10.3
|
0 Percentage or Participants
Interval 0.0 to 26.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 2.5 MonthsPopulation: All Treated Participants in Cohort 2C who achievied CR or PR
Duration of response is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the 1st objectively documented tumor progression as determined by Investigator (per RECIST 1.1), or death due to any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: approximately 2.5 MonthsPopulation: Safety Population
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression by investigator or death due to any cause, whichever is earlier.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=34 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=12 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
PFS by Investigator in Cohort 2C
|
2.89 Months
Interval 1.87 to
insufficient number of participants with events to calculate via KM methodology
|
2.04 Months
Interval 1.91 to 2.4
|
4.37 Months
Interval 1.91 to 5.32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 6 MonthsPopulation: Safety Population
Safety Related Events in Cohort 2C
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=34 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=12 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Safety Related Events in Cohort 2C
AEs
|
4 Participants
|
34 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Related Events in Cohort 2C
SAEs
|
3 Participants
|
24 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Related Events in Cohort 2C
AEs leading to discontinuation
|
0 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Safety Related Events in Cohort 2C
Deaths
|
1 Participants
|
12 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately 5 weeksPopulation: As Per Protocol, DLT Evaluable Participants in 2C.
A DLT is an adverse event or abnormal lab value not related to disease progression, illness, or other medications. The DLT evaluation period is 5 weeks (35 days) for both BMS-986288 monotherapy and combination dose escalation. Toxicities beyond this period will inform final dose decisions. Participants who discontinue due to a DLT or complete the 5-week period after receiving at least 2 doses are considered DLT-evaluable. Those who withdraw early or receive fewer than 2 doses for non-DLT reasons are not evaluable and may be replaced. Participants with dose delays for non-DLT reasons remain evaluable if they receive at least 2 doses within 8 weeks.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=1 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=8 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=1 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Dose Limiting Toxicities in Cohort 2C
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1 for Total and Intact, C4D1 for IntactPopulation: PK Evaluable Population
Cmax is defined as maximum plasma concentration of the drug.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=5 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=4 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
n=5 Participants
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=5 Participants
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=5 Participants
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=9 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=40 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 Participants
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=44 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=37 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax for Cohorts 1A, 1B and 2B
Intact, C4D1
|
25674.890 ng/mL
Geometric Coefficient of Variation 31.915
|
—
|
16700.000 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of participants for calculation of %GeoCV
|
32697.980 ng/mL
Geometric Coefficient of Variation 27.325
|
—
|
—
|
24303.414 ng/mL
Geometric Coefficient of Variation 20.997
|
30897.984 ng/mL
Geometric Coefficient of Variation 19.853
|
—
|
24900.543 ng/mL
Geometric Coefficient of Variation 30.863
|
29962.683 ng/mL
Geometric Coefficient of Variation 39.665
|
|
Cmax for Cohorts 1A, 1B and 2B
Total; C1D1
|
23583.104 ng/mL
Geometric Coefficient of Variation 15.499
|
7346.016 ng/mL
Geometric Coefficient of Variation 121.526
|
10146.620 ng/mL
Geometric Coefficient of Variation 54.040
|
35151.545 ng/mL
Geometric Coefficient of Variation 18.956
|
80443.781 ng/mL
Geometric Coefficient of Variation 19.688
|
118980.802 ng/mL
Geometric Coefficient of Variation 12.916
|
18536.692 ng/mL
Geometric Coefficient of Variation 29.410
|
32373.657 ng/mL
Geometric Coefficient of Variation 27.926
|
49789.464 ng/mL
Geometric Coefficient of Variation 16.011
|
24029.527 ng/mL
Geometric Coefficient of Variation 29.190
|
33140.927 ng/mL
Geometric Coefficient of Variation 30.622
|
|
Cmax for Cohorts 1A, 1B and 2B
Intact; C1D1
|
23165.692 ng/mL
Geometric Coefficient of Variation 13.694
|
7308.897 ng/mL
Geometric Coefficient of Variation 116.031
|
9260.703 ng/mL
Geometric Coefficient of Variation 50.656
|
37136.774 ng/mL
Geometric Coefficient of Variation 18.071
|
80597.586 ng/mL
Geometric Coefficient of Variation 20.770
|
116519.624 ng/mL
Geometric Coefficient of Variation 18.629
|
19623.300 ng/mL
Geometric Coefficient of Variation 30.309
|
33312.894 ng/mL
Geometric Coefficient of Variation 25.718
|
43461.861 ng/mL
Geometric Coefficient of Variation 19.858
|
24507.324 ng/mL
Geometric Coefficient of Variation 29.670
|
34865.711 ng/mL
Geometric Coefficient of Variation 32.039
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1 for Total and Intact, C4D1 for IntactPopulation: PK Evaluable Population
Tmax is defined is the time to maximum plasma concentration
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=5 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=4 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
n=5 Participants
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=5 Participants
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=5 Participants
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=9 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=40 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 Participants
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=44 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=37 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax for Cohorts 1A, 1B and 2B
Total; C1D1
|
0.833 Hours (H)
Interval 0.62 to 4.5
|
2.500 Hours (H)
Interval 0.52 to 76.25
|
3.725 Hours (H)
Interval 0.62 to 21.5
|
4.00 Hours (H)
Interval 0.97 to 4.5
|
4.00 Hours (H)
Interval 1.0 to 24.47
|
3.983 Hours (H)
Interval 1.0 to 4.0
|
2.933 Hours (H)
Interval 0.5 to 3.07
|
2.758 Hours (H)
Interval 0.52 to 23.72
|
3.000 Hours (H)
Interval 2.87 to 4.5
|
1.100 Hours (H)
Interval 0.5 to 69.08
|
2.800 Hours (H)
Interval 0.62 to 163.83
|
|
Tmax for Cohorts 1A, 1B and 2B
Intact; C1D1
|
4.100 Hours (H)
Interval 0.5 to 4.6
|
2.500 Hours (H)
Interval 0.52 to 76.25
|
3.725 Hours (H)
Interval 0.62 to 4.75
|
4.000 Hours (H)
Interval 0.7 to 4.5
|
1.000 Hours (H)
Interval 0.97 to 5.02
|
4.000 Hours (H)
Interval 1.0 to 4.0
|
2.933 Hours (H)
Interval 0.5 to 3.07
|
2.584 Hours (H)
Interval 0.52 to 23.72
|
0.567 Hours (H)
Interval 0.53 to 4.5
|
1.109 Hours (H)
Interval 0.52 to 69.08
|
2.683 Hours (H)
Interval 0.5 to 67.25
|
|
Tmax for Cohorts 1A, 1B and 2B
Intact; C4D1
|
2.609 Hours (H)
Interval 0.6 to 4.62
|
—
|
0.80 Hours (H)
Interval 0.8 to 0.8
|
4.000 Hours (H)
Interval 4.0 to 4.03
|
—
|
—
|
2.917 Hours (H)
Interval 0.57 to 2.92
|
1.175 Hours (H)
Interval 0.5 to 3.0
|
—
|
1.067 Hours (H)
Interval 0.1 to 22.27
|
1.942 Hours (H)
Interval 0.5 to 163.92
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1 for Total and Intact, C4D1 for IntactPopulation: PK Evaluable Population
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=5 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=4 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
n=5 Participants
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=5 Participants
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=5 Participants
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=9 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=40 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 Participants
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=44 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=37 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-T) for Cohorts 1A, 1B and 2B
Total; C1D1
|
4508154.21783 H*ng/mL
Geometric Coefficient of Variation 26.12088
|
1082346.14014 H*ng/mL
Geometric Coefficient of Variation 75.57449
|
1861226.97707 H*ng/mL
Geometric Coefficient of Variation 64.94566
|
6723961.51187 H*ng/mL
Geometric Coefficient of Variation 34.12795
|
15142162.8434 H*ng/mL
Geometric Coefficient of Variation 16.00843
|
22403650.45029 H*ng/mL
Geometric Coefficient of Variation 1.36445
|
3703077.82498 H*ng/mL
Geometric Coefficient of Variation 42.06667
|
5353398.24303 H*ng/mL
Geometric Coefficient of Variation 37.21041
|
10304729.49651 H*ng/mL
Geometric Coefficient of Variation 12.43122
|
4076700.36940 H*ng/mL
Geometric Coefficient of Variation 37.12350
|
5722320.50118 H*ng/mL
Geometric Coefficient of Variation 33.73607
|
|
AUC(0-T) for Cohorts 1A, 1B and 2B
Intact C1D1
|
3347814.86599 H*ng/mL
Geometric Coefficient of Variation 24.70946
|
896640.17927 H*ng/mL
Geometric Coefficient of Variation 69.08315
|
1351357.71064 H*ng/mL
Geometric Coefficient of Variation 50.85821
|
5142468.12364 H*ng/mL
Geometric Coefficient of Variation 32.63080
|
10800750.41369 H*ng/mL
Geometric Coefficient of Variation 24.56514
|
16484408.30096 H*ng/mL
Geometric Coefficient of Variation 32.66786
|
2741905.79748 H*ng/mL
Geometric Coefficient of Variation 44.37964
|
4235280.11485 H*ng/mL
Geometric Coefficient of Variation 35.64573
|
6885601.91062 H*ng/mL
Geometric Coefficient of Variation 16.07058
|
3132449.17983 H*ng/mL
Geometric Coefficient of Variation 36.23668
|
4572710.36078 H*ng/mL
Geometric Coefficient of Variation 31.51764
|
|
AUC(0-T) for Cohorts 1A, 1B and 2B
Intact C4D1
|
4054657.85996 H*ng/mL
Geometric Coefficient of Variation 32.35490
|
—
|
2497426.80175 H*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of events to calculate %GeoCV
|
3130520.59300 H*ng/mL
Geometric Coefficient of Variation 174.06709
|
—
|
—
|
4426043.81234 H*ng/mL
Geometric Coefficient of Variation 29.52488
|
3519951.91889 H*ng/mL
Geometric Coefficient of Variation 82.74941
|
—
|
2693455.25993 H*ng/mL
Geometric Coefficient of Variation 160.22857
|
4971148.07876 H*ng/mL
Geometric Coefficient of Variation 36.10988
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1 for Total and Intact, C4D1 for IntactPopulation: PK Evaluable Population
Area under the plasma concentration time-curve. AUC over the dosing interval.
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=5 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=4 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
n=5 Participants
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=5 Participants
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=5 Participants
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=9 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=39 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 Participants
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=44 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=35 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(Tau) for Cohorts 1A, 1B and 2B
Total; C1D1
|
4605903.87150 H*ng/mL
Geometric Coefficient of Variation 24.90666
|
1331755.67815 H*ng/mL
Geometric Coefficient of Variation 60.64583
|
2264731.07676 H*ng/mL
Geometric Coefficient of Variation 42.75268
|
6723961.51187 H*ng/mL
Geometric Coefficient of Variation 34.12795
|
16182654.45947 H*ng/mL
Geometric Coefficient of Variation 11.93735
|
23790801.57085 H*ng/mL
Geometric Coefficient of Variation 2544267
|
3918392.93186 H*ng/mL
Geometric Coefficient of Variation 36.00362
|
5591689.93928 H*ng/mL
Geometric Coefficient of Variation 31.50690
|
10304729.49651 H*ng/mL
Geometric Coefficient of Variation 12.43122
|
4322664.92642 H*ng/mL
Geometric Coefficient of Variation 30.29295
|
5910861.95661 H*ng/mL
Geometric Coefficient of Variation 31.50360
|
|
AUC(Tau) for Cohorts 1A, 1B and 2B
Intact; C1D1
|
3385414.54789 H*ng/mL
Geometric Coefficient of Variation 24.62737
|
1010308.46356 H*ng/mL
Geometric Coefficient of Variation 56.80904
|
1442135.68976 H*ng/mL
Geometric Coefficient of Variation 46.75056
|
5142468.12364 H*ng/mL
Geometric Coefficient of Variation 32.63080
|
11352433.48069 H*ng/mL
Geometric Coefficient of Variation 22.51990
|
17091968.12404 H*ng/mL
Geometric Coefficient of Variation 30.59115
|
289264.80314 H*ng/mL
Geometric Coefficient of Variation 40.11934
|
4377298.23824 H*ng/mL
Geometric Coefficient of Variation 31.63194
|
6885601.91062 H*ng/mL
Geometric Coefficient of Variation 16.07058
|
3293311.90482 H*ng/mL
Geometric Coefficient of Variation 31.99041
|
4712874.56281 H*ng/mL
Geometric Coefficient of Variation 31.65019
|
|
AUC(Tau) for Cohorts 1A, 1B and 2B
Intact; C4D1
|
4163018.66565 H*ng/mL
Geometric Coefficient of Variation 28.37040
|
—
|
2497426.80175 H*ng/mL
Geometric Coefficient of Variation NA
Insufficient number of events to calculate %GeoCV
|
6019278.27350 H*ng/mL
Geometric Coefficient of Variation 16.21812
|
—
|
—
|
4426043.81234 H*ng/mL
Geometric Coefficient of Variation 29.52488
|
4400418.11940 H*ng/mL
Geometric Coefficient of Variation 29.49927
|
—
|
3520845.93694 H*ng/mL
Geometric Coefficient of Variation 26.05394
|
5016568.84128 H*ng/mL
Geometric Coefficient of Variation 33.17484
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1 for Total and Intact, C4D1 for IntactPopulation: PK Evaluable Population
Ctau is defined as the concentration of study drug at the end of the dosing interval
Outcome measures
| Measure |
Treatment 2C: Cohort 3
n=5 Participants
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
Treatment 2C: Cohort 1
n=4 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=4 Participants
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 1A: Cohort 4
n=5 Participants
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=4 Participants
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=4 Participants
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=9 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=40 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 Participants
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=47 Participants
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=39 Participants
BMS-986288 120mg + Nivo 480mg Q4W
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
C(Tau) for Cohorts 1A, 1B and 2B
Total; C1D1
|
2756.28704 ng/mL
Geometric Coefficient of Variation 51.54927
|
323.28443 ng/mL
Geometric Coefficient of Variation 235.05609
|
1255.33355 ng/mL
Geometric Coefficient of Variation 55.24318
|
3459.203 ng/mL
Geometric Coefficient of Variation 53.635
|
7295.79216 ng/mL
Geometric Coefficient of Variation 30.41409
|
12665.79193 ng/mL
Geometric Coefficient of Variation 35.88453
|
1968.67090 ng/mL
Geometric Coefficient of Variation 86.25269
|
2006.56628 ng/mL
Geometric Coefficient of Variation 79.18517
|
5541.408 ng/mL
Geometric Coefficient of Variation 29.721
|
1855.23484 ng/mL
Geometric Coefficient of Variation 91.20240
|
2204.14352 ng/mL
Geometric Coefficient of Variation 66.31300
|
|
C(Tau) for Cohorts 1A, 1B and 2B
Intact: C1D1
|
1024.74019 ng/mL
Geometric Coefficient of Variation 78.02372
|
131.78635 ng/mL
Geometric Coefficient of Variation 184.60547
|
364.39683 ng/mL
Geometric Coefficient of Variation 100.05639
|
1423.007 ng/mL
Geometric Coefficient of Variation 72.743
|
2496.26953 ng/mL
Geometric Coefficient of Variation 57.42368
|
4683.23900 ng/mL
Geometric Coefficient of Variation 44.94995
|
732.11636 ng/mL
Geometric Coefficient of Variation 119.96752
|
765.14910 ng/mL
Geometric Coefficient of Variation 112.89925
|
5145.910 ng/mL
Geometric Coefficient of Variation 22.999
|
799.46828 ng/mL
Geometric Coefficient of Variation 95.65148
|
935.75687 ng/mL
Geometric Coefficient of Variation 91.60647
|
|
C(Tau) for Cohorts 1A, 1B and 2B
Intact; C4D1
|
1365.54472 ng/mL
Geometric Coefficient of Variation 118.69550
|
—
|
687.000 ng/mL
Geometric Coefficient of Variation NA
Insufficient number of events to calculate %GeoCv
|
2082.90863 ng/mL
Geometric Coefficient of Variation 41.58557
|
—
|
—
|
1940.311 ng/mL
Geometric Coefficient of Variation 33.795
|
1123.88313 ng/mL
Geometric Coefficient of Variation 87368335
|
—
|
907.65893 ng/mL
Geometric Coefficient of Variation 76.11507
|
1155.32105 ng/mL
Geometric Coefficient of Variation 64.19719
|
Adverse Events
Treatment 1A: Cohort 1
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Treatment 1A: Cohort 2
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Treatment 1A: Cohort 3
Serious events: 4 serious events
Other events: 5 other events
Deaths: 5 deaths
Treatment 1A: Cohort 4
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Treatment 1A: Cohort 5
Serious events: 5 serious events
Other events: 5 other events
Deaths: 3 deaths
Treatment 1A: Cohort 6
Serious events: 5 serious events
Other events: 5 other events
Deaths: 5 deaths
Treatment 1B: Cohort 1
Serious events: 4 serious events
Other events: 9 other events
Deaths: 5 deaths
Treatment 1B: Cohort 2
Serious events: 29 serious events
Other events: 40 other events
Deaths: 26 deaths
Treatment 1B: Cohort 3
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Treatment 2B: Cohort 1
Serious events: 34 serious events
Other events: 47 other events
Deaths: 34 deaths
Treatment 2B: Cohort 2
Serious events: 30 serious events
Other events: 39 other events
Deaths: 30 deaths
Treatment 2C: Cohort 1
Serious events: 24 serious events
Other events: 34 other events
Deaths: 12 deaths
Treatment 2C: Cohort 2
Serious events: 7 serious events
Other events: 12 other events
Deaths: 6 deaths
Treatment 2C: Cohort 3
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment 1A: Cohort 1
n=4 participants at risk
BMS-986288 BMS 20mg Q4W
|
Treatment 1A: Cohort 2
n=4 participants at risk
BMS-986288 40mg Q4W
|
Treatment 1A: Cohort 3
n=5 participants at risk
BMS-986288 80mg Q4W
|
Treatment 1A: Cohort 4
n=6 participants at risk
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=5 participants at risk
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=5 participants at risk
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=9 participants at risk
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=40 participants at risk
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 participants at risk
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=47 participants at risk
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=39 participants at risk
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 1
n=34 participants at risk
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=12 participants at risk
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 2C: Cohort 3
n=4 participants at risk
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.5%
4/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Death
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Disease progression
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.7%
5/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Generalised oedema
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.3%
4/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Sudden death
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lung abscess
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Peritonitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.5%
4/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.3%
4/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Tracheitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Troponin I increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
80.0%
4/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
10/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
27.7%
13/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.5%
8/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.7%
5/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour perforation
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Malignant spinal cord compression
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.8%
5/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
3/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.8%
3/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Surgical and medical procedures
Assisted suicide
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Treatment 1A: Cohort 1
n=4 participants at risk
BMS-986288 BMS 20mg Q4W
|
Treatment 1A: Cohort 2
n=4 participants at risk
BMS-986288 40mg Q4W
|
Treatment 1A: Cohort 3
n=5 participants at risk
BMS-986288 80mg Q4W
|
Treatment 1A: Cohort 4
n=6 participants at risk
BMS-986288 160mg Q4W
|
Treatment 1A: Cohort 5
n=5 participants at risk
BMS-986288 320mg Q4W
|
Treatment 1A: Cohort 6
n=5 participants at risk
BMS-986288 480mg Q4W
|
Treatment 1B: Cohort 1
n=9 participants at risk
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 2
n=40 participants at risk
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 1B: Cohort 3
n=3 participants at risk
BMS-986288 160mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 1
n=47 participants at risk
BMS-986288 80mg + Nivo 480mg Q4W
|
Treatment 2B: Cohort 2
n=39 participants at risk
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 1
n=34 participants at risk
BMS-986288 120mg + Nivo 480mg Q4W
|
Treatment 2C: Cohort 2
n=12 participants at risk
Regorafenib 160mg PO QD first 21 days of 28-day cycle
|
Treatment 2C: Cohort 3
n=4 participants at risk
BMS-986288 120mg + Nivo 480mg Q4W (Crossover from Treatment 2C: Cohort 2)
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.5%
15/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.4%
11/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.4%
6/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
17/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
6/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.8%
4/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.8%
3/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
3/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.8%
3/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Asthenopia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Cataract
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.8%
3/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Glaucoma
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Iritis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Keratitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Visual impairment
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
5/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
3/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
75.0%
3/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
4/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.4%
6/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.6%
6/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
3/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
44.4%
4/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
32.5%
13/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
38.3%
18/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.4%
6/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
35.3%
12/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
6/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
3/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Loose tooth
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
8/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.9%
7/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.4%
6/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.6%
6/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Proctalgia
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
3/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
4/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.6%
5/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.3%
4/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.8%
4/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
4/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.5%
12/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.1%
9/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.8%
4/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
4/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chest pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chills
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Device related thrombosis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Face oedema
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
2/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
60.0%
3/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
44.4%
4/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
10/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.5%
12/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.1%
9/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
32.4%
11/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
6/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
General physical health deterioration
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Localised oedema
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
4/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
3/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.8%
3/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.1%
9/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.4%
6/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.6%
7/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
4/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Suprapubic pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Xerosis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Ocular icterus
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Anal abscess
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.8%
6/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
3/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Groin abscess
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Impetigo
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lung abscess
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oesophageal infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Periodontitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pilonidal disease
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
3/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
3/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.8%
4/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.8%
4/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
3/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.5%
9/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.3%
4/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.5%
8/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
4/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Amylase increased
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
5/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.6%
6/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.0%
12/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.8%
5/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
41.2%
14/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
58.3%
7/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
5/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.0%
8/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.3%
4/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.5%
8/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood albumin increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
5/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood bilirubin abnormal
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.0%
6/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.6%
7/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
6/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood calcium decreased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
3/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood calcium increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
4/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.1%
9/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.6%
6/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.8%
4/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
8/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.5%
4/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.6%
6/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood glucose increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.0%
8/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
3/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
3/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
3/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood potassium increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood sodium decreased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.8%
6/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
3/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood sodium increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.8%
3/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
41.7%
5/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood uric acid increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
C-reactive protein increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Coagulation test abnormal
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Eosinophil count increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Gamma-glutamyltransferase increased
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
5/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Lipase increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.5%
9/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.6%
5/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.8%
5/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.5%
8/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
3/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Liver function test increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Monocyte count increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Neutrophil count increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Pancreatic enzymes increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Transaminases increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Troponin I increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Troponin T increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Troponin increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
3/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
5/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.4%
11/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.3%
4/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.6%
7/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
3/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight increased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.5%
9/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.5%
12/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.4%
6/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.6%
7/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
41.7%
5/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.5%
4/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.8%
3/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
4/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.8%
3/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.8%
4/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.5%
9/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.6%
5/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Underweight
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
4/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
75.0%
3/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.5%
4/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.8%
5/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.7%
5/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
4/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.5%
4/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
3/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
2/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Fine motor skill dysfunction
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
3/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.6%
7/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
3/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hypoaesthesia
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Myasthenic syndrome
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Paresis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Spinal cord compression
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
2/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.8%
4/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
3/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Nipple pain
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
3/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.5%
7/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.0%
8/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.3%
4/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.6%
7/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
4/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.0%
6/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.6%
5/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.8%
5/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.8%
4/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
2/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.5%
4/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
3/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
3/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.4%
3/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
3/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.8%
6/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
3/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.8%
4/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.5%
3/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.3%
2/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
3/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
5/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.9%
2/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.3%
1/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.0%
2/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Flushing
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
16.7%
1/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
5/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.7%
3/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.8%
4/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
58.3%
7/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.1%
2/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.5%
1/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Neurogenic shock
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.6%
1/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
1/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/6 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/40 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.1%
1/47 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/39 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/34 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/12 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: Approximately 6 Months All-Cause mortality (From randomization to end of study): Approximately 5 years
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER