Trial Outcomes & Findings for A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer (NCT NCT05543629)
NCT ID: NCT05543629
Last Updated: 2025-03-18
Results Overview
Number of Participants with Adverse Events. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. For the reporting of all AEs, including intensity or severity, on case report forms, please follow the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
From first dose to 100 days post last dose (Approximately 6 Months)
Results posted on
2025-03-18
Participant Flow
Participant milestones
| Measure |
Part A: Treatment 1
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
4
|
3
|
3
|
7
|
8
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
4
|
3
|
3
|
7
|
8
|
3
|
Reasons for withdrawal
| Measure |
Part A: Treatment 1
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
1
|
0
|
0
|
1
|
2
|
2
|
|
Overall Study
Other Reasons
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
3
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Study terminated by Sponsor
|
1
|
0
|
0
|
1
|
0
|
4
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
2
|
1
|
1
|
1
|
1
|
|
Overall Study
Not Reported
|
2
|
2
|
0
|
0
|
1
|
1
|
3
|
0
|
Baseline Characteristics
A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
58.4 Years
STANDARD_DEVIATION 7.50 • n=5 Participants
|
66.3 Years
STANDARD_DEVIATION 1.15 • n=7 Participants
|
66.2 Years
STANDARD_DEVIATION 7.41 • n=5 Participants
|
76.3 Years
STANDARD_DEVIATION 3.79 • n=4 Participants
|
57.3 Years
STANDARD_DEVIATION 9.71 • n=21 Participants
|
65.3 Years
STANDARD_DEVIATION 8.86 • n=8 Participants
|
60.1 Years
STANDARD_DEVIATION 11.41 • n=8 Participants
|
65.7 Years
STANDARD_DEVIATION 1.53 • n=24 Participants
|
63.7 Years
STANDARD_DEVIATION 9.13 • n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
34 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
29 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose (Approximately 6 Months)Population: All Treated Participants
Number of Participants with Adverse Events. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. For the reporting of all AEs, including intensity or severity, on case report forms, please follow the definitions in National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Outcome measures
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
5 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
8 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose (Approximately 6 Months)Population: All Treated Participants
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization
Outcome measures
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events
|
3 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose (Approximately 6 Months)Population: All Treated Participants
Number of Participants with adverse events leading to discontinuation
Outcome measures
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events Leading to Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Cycle 1 day 1 to day 28 (28 Days)Population: All Treated Participants
DLTs will be defined based on the incidence, intensity, and duration of the AEs for which no clear alternative cause is identified and will exclude events clearly related to disease progression or intercurrent illness. in addition, the following AEs will be DLTs: * Any death that is not clearly due to the underlying disease or extraneous causes * Any Grade ≥ 3 non-hematological toxicity * Any Grade myocarditis * Any Grade myelitis, encephalitis, myasthenia gravis, or Guillain-Barre syndrome * Grade 4 neutropenia of \> 7 days duration * Grade 4 thrombocytopenia. * Grade 3 thrombocytopenia with clinically significant bleeding. * Febrile neutropenia Any AE that is not clearly due to disease progression or extraneous causes that occurs within the 28-day DLT evaluation window and meets criteria for permanent discontinuation will be considered a DLT.
Outcome measures
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose (Approximately 6 Months)Population: All Treated Participants
Number of Participants who died
Outcome measures
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Died
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)Population: PK evaluable population
Maximum observed serum concentration
Outcome measures
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
CMax
Cycle 1 Day 1
|
6.47 ug/mL
Geometric Coefficient of Variation 12.07
|
20.66 ug/mL
Geometric Coefficient of Variation 31.27
|
84.64 ug/mL
Geometric Coefficient of Variation 12.90
|
213.29 ug/mL
Geometric Coefficient of Variation 24.73
|
607.16 ug/mL
Geometric Coefficient of Variation 30.57
|
188.17 ug/mL
Geometric Coefficient of Variation 12.48
|
525.77 ug/mL
Geometric Coefficient of Variation 63.12
|
278.89 ug/mL
Geometric Coefficient of Variation 9.14
|
|
CMax
Cycle 4 Day 1
|
7.53 ug/mL
Geometric Coefficient of Variation 13.81
|
28.60 ug/mL
Geometric Coefficient of Variation NA
Insufficient number of participants analyzed to calculate geometric coefficient of variation
|
88.92 ug/mL
Geometric Coefficient of Variation 26.63
|
239.00 ug/mL
Geometric Coefficient of Variation NA
Insufficient number of participants analyzed to calculate geometric coefficient of variation
|
595.00 ug/mL
Geometric Coefficient of Variation NA
Insufficient number of participants analyzed to calculate geometric coefficient of variation
|
161.37 ug/mL
Geometric Coefficient of Variation 20.29
|
345.40 ug/mL
Geometric Coefficient of Variation 25.64
|
—
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)Population: PK evaluable population
Time of maximum observed serum concentration
Outcome measures
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Tmax
Cycle 1 Day 1
|
4.0 hours
Interval 1.0 to 4.0
|
1.17 hours
Interval 1.0 to 2.7
|
1.52 hours
Interval 1.2 to 2.5
|
1.77 hours
Interval 1.0 to 2.1
|
4.05 hours
Interval 0.3 to 22.4
|
1.27 hours
Interval 1.0 to 4.0
|
1.67 hours
Interval 1.0 to 4.0
|
1.67 hours
Interval 1.5 to 4.0
|
|
Tmax
Cycle 4 Day 1
|
1.22 hours
Interval 1.0 to 3.0
|
3.88 hours
Interval 3.88 to 3.88
|
1.23 hours
Interval 1.1 to 1.4
|
3.93 hours
Interval 3.93 to 3.93
|
23.98 hours
Interval 23.98 to 23.98
|
13.94 hours
Interval 3.0 to 24.9
|
5.50 hours
Interval 3.9 to 5.5
|
—
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1 and on Cycle 4 Day 1 (Each cycle = 3 Weeks)Population: PK evaluable population
Area under the serum concentration-time curve in 1 dosing interval
Outcome measures
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
AUC (Tau)
Cycle 1 Day 1
|
697.89 h*ug/mL
Geometric Coefficient of Variation 22.59
|
2182.10 h*ug/mL
Geometric Coefficient of Variation 60.66
|
10412.98 h*ug/mL
Geometric Coefficient of Variation 19.48
|
31421.18 h*ug/mL
Geometric Coefficient of Variation 14.61
|
92086.95 h*ug/mL
Geometric Coefficient of Variation 42.72
|
23544.68 h*ug/mL
Geometric Coefficient of Variation 21.49
|
59747.91 h*ug/mL
Geometric Coefficient of Variation 26.15
|
28983.46 h*ug/mL
Geometric Coefficient of Variation 22.78
|
|
AUC (Tau)
Cycle 4 Day 1
|
650.12 h*ug/mL
Geometric Coefficient of Variation 91.31
|
4048.56 h*ug/mL
Geometric Coefficient of Variation NA
Insufficient number of participants analyzed to calculate geometric coefficient of variation
|
6965.42 h*ug/mL
Geometric Coefficient of Variation 24.78
|
42581.54 h*ug/mL
Geometric Coefficient of Variation NA
Insufficient number of participants analyzed to calculate geometric coefficient of variation
|
129835.00 h*ug/mL
Geometric Coefficient of Variation NA
Insufficient number of participants analyzed to calculate geometric coefficient of variation
|
31371.02 h*ug/mL
Geometric Coefficient of Variation NA
Insufficient number of participants analyzed to calculate geometric coefficient of variation
|
42688.89 h*ug/mL
Geometric Coefficient of Variation 19.18
|
—
|
SECONDARY outcome
Timeframe: From first dose to 100 days post last dose (Approximately 6 Months)Population: All Treated Participants with baseline and at least one post-baseline evaluable ADA assessment
Number of participants with BMS-986442 Anti Drug Antibody (ADA)
Outcome measures
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=2 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=7 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=2 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With BMS-986442 Anti Drug Antibody (ADA)
Baseline ADA Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With BMS-986442 Anti Drug Antibody (ADA)
ADA Positive
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With BMS-986442 Anti Drug Antibody (ADA)
ADA Persistent Positive
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With BMS-986442 Anti Drug Antibody (ADA)
ADA Not PP- Last sample postive
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With BMS-986442 Anti Drug Antibody (ADA)
Other Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With BMS-986442 Anti Drug Antibody (ADA)
ADA Negative
|
5 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose to 100 days post last dose (Approximately 6 Months)Population: All Treated Participants
ORR is defined as the number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) assessed by Investigator, according to RECIST v1.1 criteria, divided by the number of treated participants. The BOR is defined as the best response designation recorded between the date of first dose and the date of initial objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination. For purposes of analysis, if a participant receives one dose and discontinues the study without assessment or receives subsequent therapy prior to assessment, this participant will be counted in the denominator (as nonrespondent).
Outcome measures
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Per Recist v1.1 by Investigator
|
20.0 Percentage of Participants
Interval 0.5 to 71.6
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 60.2
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
0 Percentage of Participants
Interval 0.0 to 36.9
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
SECONDARY outcome
Timeframe: From first dose to 100 days post last dose (Approximately 6 Months)Population: All Treated Participants
Disease Control Rate (DCR) is defined as the number of treated participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) (and/or SD \> 6 months), based on investigator assessments divided by the number of all treated participants.
Outcome measures
| Measure |
Part A: Treatment 1
n=5 Participants
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 Participants
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 Participants
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treatment 5
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 Participants
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 Participants
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR) Per Recist v1.1 by Investigator
|
20.0 Percentage of Participants
Interval 0.5 to 71.6
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
25.0 Percentage of Participants
Interval 0.6 to 80.6
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
66.7 Percentage of Participants
Interval 9.4 to 99.2
|
14.3 Percentage of Participants
Interval 0.4 to 57.9
|
12.5 Percentage of Participants
Interval 0.3 to 52.7
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
Adverse Events
Part A: Treatment 1
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Part A: Treatment 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Treatment 3
Serious events: 4 serious events
Other events: 4 other events
Deaths: 3 deaths
Part A: Treatment 4
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: Treamtent 5
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Part B1: Treatment 1
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Part B1: Treatment 2
Serious events: 6 serious events
Other events: 7 other events
Deaths: 2 deaths
Part B2: Treatment 1
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Part A: Treatment 1
n=5 participants at risk
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 participants at risk
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 participants at risk
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 participants at risk
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treamtent 5
n=3 participants at risk
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 participants at risk
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 participants at risk
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 participants at risk
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Atrioventricular block second degree
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Myocardial infarction
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Conjunctival haemorrhage
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cytokine release syndrome
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
75.0%
3/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Epilepsy
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 |
Part A: Treatment 1
n=5 participants at risk
BMS-986442 20mg + Nivo 360mg QW
|
Part A: Treatment 2
n=3 participants at risk
BMS-986442 60mg + Nivo 360mg QW
|
Part A: Treatment 3
n=4 participants at risk
BMS-986442 200mg + Nivo 360mg QW
|
Part A: Treatment 4
n=3 participants at risk
BMS-986442 600mg + Nivo 360mg QW
|
Part A: Treamtent 5
n=3 participants at risk
BMS-986442 1200mg + Nivo 360mg QW
|
Part B1: Treatment 1
n=7 participants at risk
BMS-986442 600mg + Nivo 360mg QW
|
Part B1: Treatment 2
n=8 participants at risk
BMS-986442 1200mg + Nivo 360mg QW
|
Part B2: Treatment 1
n=3 participants at risk
BMS-986442 1200mg + Nivo 360mg QW
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Ventricular arrhythmia
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Adrenal insufficiency
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.5%
3/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oesophagitis
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Salivary hypersecretion
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
3/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Catheter site pain
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chest discomfort
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chest pain
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infusion site extravasation
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Xerosis
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypersensitivity
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Candida infection
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oral candidiasis
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Otitis media
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood calcium increased
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatine phosphokinase increased
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Gamma-glutamyltransferase increased
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Influenza A virus test positive
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Lipase increased
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Troponin I increased
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Troponin increased
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
2/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.5%
3/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Extrapyramidal disorder
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lethargy
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Sinus headache
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Perineal rash
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Throat irritation
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Blister
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 dystrophy
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
4/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
40.0%
2/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
66.7%
2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 exfoliation
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Xeroderma
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
20.0%
1/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
1/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Superficial vein thrombosis
|
0.00%
0/5 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/4 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately on average up to 6 months with a maximum of 16 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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: 1-855-907-3286
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