Trial Outcomes & Findings for Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study (NCT NCT04887870)
NCT ID: NCT04887870
Last Updated: 2026-08-04
Results Overview
An AE is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Assessment of AEs will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 5.0\]), timing, seriousness, and relatedness to study treatment. A treatment-emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any pre-existing condition that increases in severity after the first dose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
49 participants
Primary outcome timeframe
Approximately up to 80.5 weeks
Results posted on
2026-08-04
Participant Flow
49 Participants enrolled and treated from 6 different parent studies
Participant milestones
| Measure |
Parent Study 1
Sitravatinib Monotherapy
|
Parent Study 2
Sitravatinib + Nivolumab: MRTX-500
|
Parent Study 3
Sitravatinib + Nivolumab: 516-003
|
Parent Study 4
Sitravatinib + Nivolumab: 516-008
|
Parent Study 5
Sitravatinib + Nivolumab: 516-010
|
Parent Study 6
Sitravatinib + Pembrolizumab + Enfortumab
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
14
|
3
|
21
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
14
|
3
|
21
|
1
|
Reasons for withdrawal
| Measure |
Parent Study 1
Sitravatinib Monotherapy
|
Parent Study 2
Sitravatinib + Nivolumab: MRTX-500
|
Parent Study 3
Sitravatinib + Nivolumab: 516-003
|
Parent Study 4
Sitravatinib + Nivolumab: 516-008
|
Parent Study 5
Sitravatinib + Nivolumab: 516-010
|
Parent Study 6
Sitravatinib + Pembrolizumab + Enfortumab
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
0
|
2
|
1
|
|
Overall Study
Global deterioration of health
|
0
|
0
|
3
|
0
|
2
|
0
|
|
Overall Study
investigator decision
|
0
|
0
|
0
|
0
|
6
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
0
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
2
|
0
|
2
|
0
|
|
Overall Study
study terminated by sponsor
|
4
|
2
|
5
|
2
|
1
|
0
|
|
Overall Study
other reasons
|
0
|
2
|
0
|
1
|
7
|
0
|
Baseline Characteristics
Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study
Baseline characteristics by cohort
| Measure |
Parent Study 2
n=4 Participants
Sitravatinib + Nivolumab: MRTX-500
|
Parent Study 3
n=14 Participants
Sitravatinib + Nivolumab: 516-003
|
Parent Study 5
n=21 Participants
Sitravatinib + Nivolumab: 516-010
|
Parent Study 4
n=3 Participants
Sitravatinib + Nivolumab: 516-008
|
Parent Study 6
n=1 Participants
Sitravatinib + Pembrolizumab + Enfortumab
|
Total
n=49 Participants
Total of all reporting groups
|
Parent Study 1
n=6 Participants
Sitravatinib Monotherapy
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 11.03 • n=20 Participants
|
69.2 years
STANDARD_DEVIATION 6.81 • n=40 Participants
|
56.2 years
STANDARD_DEVIATION 16.03 • n=6 Participants
|
43.3 years
STANDARD_DEVIATION 8.50 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 64.0 • n=13 Participants
|
60.9 years
STANDARD_DEVIATION 13.91 • n=6 Participants
|
63.7 years
STANDARD_DEVIATION 10.46 • n=20 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
15 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
25 Participants
n=6 Participants
|
2 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
6 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
24 Participants
n=6 Participants
|
4 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
7 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
8 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
10 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
37 Participants
n=6 Participants
|
6 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
12 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
39 Participants
n=6 Participants
|
6 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 80.5 weeksPopulation: All Treated Participants
An AE is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Assessment of AEs will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 5.0\]), timing, seriousness, and relatedness to study treatment. A treatment-emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any pre-existing condition that increases in severity after the first dose of study treatment.
Outcome measures
| Measure |
Parent Study 1
n=6 Participants
Sitravatinib Monotherapy
|
Parent Study 2
n=4 Participants
Sitravatinib + Nivolumab: MRTX-500
|
Parent Study 3
n=14 Participants
Sitravatinib + Nivolumab: 516-003
|
Parent Study 4
n=3 Participants
Sitravatinib + Nivolumab: 516-008
|
Parent Study 5
n=21 Participants
Sitravatinib + Nivolumab: 516-010
|
Parent Study 6
n=1 Participants
Sitravatinib + Pembrolizumab + Enfortumab
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Related Adverse Events.
Any TEAE
|
6 Participants
|
4 Participants
|
13 Participants
|
3 Participants
|
21 Participants
|
1 Participants
|
|
Number of Participants With Treatment Related Adverse Events.
Any Grade 3 or higher TEAE
|
4 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
16 Participants
|
1 Participants
|
|
Number of Participants With Treatment Related Adverse Events.
Serious TEAE
|
1 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
10 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 80.5 weeksPopulation: All Treated Participants
Number of participants with treatment related adverse events which lead to study drug discontinuation.
Outcome measures
| Measure |
Parent Study 1
n=6 Participants
Sitravatinib Monotherapy
|
Parent Study 2
n=4 Participants
Sitravatinib + Nivolumab: MRTX-500
|
Parent Study 3
n=14 Participants
Sitravatinib + Nivolumab: 516-003
|
Parent Study 4
n=3 Participants
Sitravatinib + Nivolumab: 516-008
|
Parent Study 5
n=21 Participants
Sitravatinib + Nivolumab: 516-010
|
Parent Study 6
n=1 Participants
Sitravatinib + Pembrolizumab + Enfortumab
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Related Adverse Events Which Lead to Study Drug Discontinuation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Approximately up to 80.5 weeksPopulation: All Treated Participants
An abnormal laboratory test result should be reported as an AE in the CRF only if it is associated with one or more of the following: * Clinical symptoms; * Requires additional tests (beyond repeats), treatment, or intervention; * Results in change in study treatment dosing; * Requires discontinuation from study treatment; and/or * Considered by the investigator or sponsor to be an AE.
Outcome measures
| Measure |
Parent Study 1
n=6 Participants
Sitravatinib Monotherapy
|
Parent Study 2
n=4 Participants
Sitravatinib + Nivolumab: MRTX-500
|
Parent Study 3
n=14 Participants
Sitravatinib + Nivolumab: 516-003
|
Parent Study 4
n=3 Participants
Sitravatinib + Nivolumab: 516-008
|
Parent Study 5
n=21 Participants
Sitravatinib + Nivolumab: 516-010
|
Parent Study 6
n=1 Participants
Sitravatinib + Pembrolizumab + Enfortumab
|
|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Parent Study 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Parent Study 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Parent Study 3
Serious events: 5 serious events
Other events: 14 other events
Deaths: 3 deaths
Parent Study 4
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Parent Study 5
Serious events: 10 serious events
Other events: 21 other events
Deaths: 4 deaths
Parent Study 6
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Parent Study 1
n=6 participants at risk
Sitravatinib Monotherapy
|
Parent Study 2
n=4 participants at risk
Sitravatinib + Nivolumab: MRTX-500
|
Parent Study 3
n=14 participants at risk
Sitravatinib + Nivolumab: 516-003
|
Parent Study 4
n=3 participants at risk
Sitravatinib + Nivolumab: 516-008
|
Parent Study 5
n=21 participants at risk
Sitravatinib + Nivolumab: 516-010
|
Parent Study 6
n=1 participants at risk
Sitravatinib + Pembrolizumab + Enfortumab
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Demyelination
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Pelvic infection
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
3/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Cerebrovascular accident
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Encephalopathy
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Pelvic fluid collection
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Vaginal haemorrhage
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Large intestinal obstruction
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Cholelithiasis
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Endocarditis
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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 |
Parent Study 1
n=6 participants at risk
Sitravatinib Monotherapy
|
Parent Study 2
n=4 participants at risk
Sitravatinib + Nivolumab: MRTX-500
|
Parent Study 3
n=14 participants at risk
Sitravatinib + Nivolumab: 516-003
|
Parent Study 4
n=3 participants at risk
Sitravatinib + Nivolumab: 516-008
|
Parent Study 5
n=21 participants at risk
Sitravatinib + Nivolumab: 516-010
|
Parent Study 6
n=1 participants at risk
Sitravatinib + Pembrolizumab + Enfortumab
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiomyopathy
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Ear pain
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Anaemia
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
4/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Tinnitus
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
100.0%
6/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
57.1%
8/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
42.9%
9/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Lacrimation increased
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.8%
5/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
4/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
100.0%
6/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
4/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
64.3%
9/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
3/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
76.2%
16/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Diverticulum
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Gastric ulcer
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Glossodynia
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Lip dry
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
47.6%
10/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Periodontal disease
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.0%
4/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Toothache
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
38.1%
8/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Early satiety
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Facial pain
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
100.0%
6/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
4/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
71.4%
10/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
61.9%
13/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Malaise
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
4/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Temperature intolerance
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Cholelithiasis
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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 steatosis
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Seasonal allergy
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Cystitis
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Enterococcal sepsis
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Eye infection
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Paronychia
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Sialoadenitis
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Sinusitis
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Vaginal infection
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Contusion
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Exposure to SARS-CoV-2
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Overdose
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Rib fracture
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Stoma site haemorrhage
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
42.9%
6/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
3/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.0%
4/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
4/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
42.9%
6/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
3/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
66.7%
4/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
7/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
3/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Haemoglobin increased
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
International normalised ratio increased
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
4/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
4/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
SARS-CoV-2 test positive
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
6/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Cachexia
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.8%
5/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
6/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Diabetes mellitus
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Fluid overload
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
3/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
35.7%
5/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Hyperlipidaemia
|
50.0%
3/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Hypertriglyceridaemia
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
50.0%
3/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
4/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.0%
4/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
35.7%
5/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
66.7%
4/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
42.9%
6/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
3/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
35.7%
5/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Bursitis
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Intervertebral disc protrusion
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Trigger finger
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Amnesia
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Carpal tunnel syndrome
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
3/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Loss of consciousness
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Neuralgia
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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 motor neuropathy
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
4/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Radiculopathy
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Restless legs syndrome
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Tremor
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Agitation
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Bladder spasm
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Chronic kidney disease
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Glycosuria
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
50.0%
3/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
4/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Micturition urgency
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Nocturia
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
50.0%
3/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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 incontinence
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Breast pain
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Pelvic pain
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Penile discharge
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Vulvovaginal dryness
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
66.7%
4/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
35.7%
5/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
4/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.0%
4/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
50.0%
3/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Emphysema
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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 dryness
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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 hypertension
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Rhinorrhoea
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Sinus pain
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Actinic elastosis
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Alopecia
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
3/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Nail discolouration
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
Pain of skin
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
28.6%
6/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
50.0%
3/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.0%
4/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
100.0%
1/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
16.7%
1/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.3%
2/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
23.8%
5/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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 ulcer
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
2/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.4%
3/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
|
33.3%
2/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
71.4%
10/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
38.1%
8/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
1/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
1/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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
White coat hypertension
|
0.00%
0/6 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/14 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/21 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/1 • Adverse Events, Serious Adverse Events and All-Cause Mortality: (From first dose to last dose + 100 days): Approximately up to 80.5 weeks
The number at Risk for All-Cause Mortality represents all treated participants. The number at 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