Trial Outcomes & Findings for An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions (NCT NCT04717414)
NCT ID: NCT04717414
Last Updated: 2026-07-16
Results Overview
Percentage of participants who become RBC-transfusion free over any consecutive 12-week period starting in first 24 weeks.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
313 participants
Primary outcome timeframe
From randomization to week 36 (Approximately 36 Weeks)
Results posted on
2026-07-16
Participant Flow
313 Participants randomized to trial
Participant milestones
| Measure |
Treatment
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
|---|---|---|
|
Blinded Core Treatment Period
STARTED
|
208
|
105
|
|
Blinded Core Treatment Period
COMPLETED
|
156
|
88
|
|
Blinded Core Treatment Period
NOT COMPLETED
|
52
|
17
|
|
42 Day Follow Up Period
STARTED
|
116
|
74
|
|
42 Day Follow Up Period
COMPLETED
|
105
|
70
|
|
42 Day Follow Up Period
NOT COMPLETED
|
11
|
4
|
|
Open Label Extension Period
STARTED
|
0
|
42
|
|
Open Label Extension Period
COMPLETED
|
0
|
12
|
|
Open Label Extension Period
NOT COMPLETED
|
0
|
30
|
|
Open Label 42 Day Follow Up Period
STARTED
|
0
|
23
|
|
Open Label 42 Day Follow Up Period
COMPLETED
|
0
|
23
|
|
Open Label 42 Day Follow Up Period
NOT COMPLETED
|
0
|
0
|
|
Survival Follow Up Period
STARTED
|
105
|
51
|
|
Survival Follow Up Period
COMPLETED
|
0
|
0
|
|
Survival Follow Up Period
NOT COMPLETED
|
105
|
51
|
Reasons for withdrawal
| Measure |
Treatment
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
|---|---|---|
|
Blinded Core Treatment Period
Withdrawal by Subject
|
22
|
6
|
|
Blinded Core Treatment Period
Adverse Event
|
10
|
5
|
|
Blinded Core Treatment Period
Death
|
9
|
3
|
|
Blinded Core Treatment Period
Other Reasons
|
4
|
3
|
|
Blinded Core Treatment Period
Progressive Disease
|
5
|
0
|
|
Blinded Core Treatment Period
Lost to Follow-up
|
1
|
0
|
|
Blinded Core Treatment Period
Not Treated
|
1
|
0
|
|
42 Day Follow Up Period
Death
|
7
|
3
|
|
42 Day Follow Up Period
Withdrawal by Subject
|
3
|
1
|
|
42 Day Follow Up Period
Still On-Going
|
1
|
0
|
|
Open Label Extension Period
Lack of Efficacy
|
0
|
13
|
|
Open Label Extension Period
Withdrawal by Subject
|
0
|
5
|
|
Open Label Extension Period
No Longer Clinically Benefiting
|
0
|
4
|
|
Open Label Extension Period
Adverse Event
|
0
|
3
|
|
Open Label Extension Period
Other Reasons
|
0
|
2
|
|
Open Label Extension Period
Progressive Disease
|
0
|
2
|
|
Open Label Extension Period
Death
|
0
|
1
|
|
Survival Follow Up Period
Death
|
26
|
17
|
|
Survival Follow Up Period
Withdrawal by Subject
|
24
|
6
|
|
Survival Follow Up Period
Lost to Follow-up
|
3
|
1
|
|
Survival Follow Up Period
Still On-Going
|
52
|
27
|
Baseline Characteristics
An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions
Baseline characteristics by cohort
| Measure |
Treatment
n=208 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Total
n=313 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.5 Years
STANDARD_DEVIATION 8.74 • n=9 Participants
|
71.5 Years
STANDARD_DEVIATION 9.45 • n=27 Participants
|
70.9 Years
STANDARD_DEVIATION 8.98 • n=267 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=9 Participants
|
36 Participants
n=27 Participants
|
125 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=9 Participants
|
69 Participants
n=27 Participants
|
188 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=9 Participants
|
7 Participants
n=27 Participants
|
18 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
186 Participants
n=9 Participants
|
92 Participants
n=27 Participants
|
278 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
17 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
65 Participants
n=9 Participants
|
34 Participants
n=27 Participants
|
99 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
126 Participants
n=9 Participants
|
60 Participants
n=27 Participants
|
186 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: From randomization to week 36 (Approximately 36 Weeks)Population: Intent to Treat Population
Percentage of participants who become RBC-transfusion free over any consecutive 12-week period starting in first 24 weeks.
Outcome measures
| Measure |
Treatment
n=208 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Red Blood Cell-transfusion Independence (RBC-TI) ≥ 12 Weeks (RBC-TI 12)
|
23.08 Percentage of Participants
Interval 17.53 to 29.41
|
13.33 Percentage of Participants
Interval 7.49 to 21.36
|
—
|
SECONDARY outcome
Timeframe: From randomization to week 40 (Approximately 40 Weeks)Population: Intent to Treat Population
Percentage of participants who become RBC-transfusion free over any consecutive 16-week period starting in first 24 weeks.
Outcome measures
| Measure |
Treatment
n=208 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Red Blood Cell-transfusion Independence (RBC-TI) ≥ 16 Weeks (RBC-TI 16)
|
19.23 Percentage of Participants
Interval 14.11 to 25.25
|
11.43 Percentage of Participants
Interval 6.05 to 19.11
|
—
|
SECONDARY outcome
Timeframe: From randomization to data cutoff date (Approximately 48.92 Months)Population: Participants who achieved at least one RBC-TI 12 weeks starting in the first 24 weeks
Maximum observed duration of response of RBC-TI 12
Outcome measures
| Measure |
Treatment
n=48 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=14 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Observed Duration of Response of RBC-TI 12
|
43.79 Weeks
Interval 20.64 to 91.79
|
37.43 Weeks
Interval 25.0 to 67.0
|
—
|
SECONDARY outcome
Timeframe: Randomization up to week 36 (Approximately week 36)Population: Intent to Treat Population
Percentage of participants who reduce their transfusion burden by ≥ 50% and by ≥ 4 units/12 weeks from baseline over any consecutive 12- week period. Starting in first 24 weeks.
Outcome measures
| Measure |
Treatment
n=208 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Reduction in Transfusion Burden
|
85 Participants
|
24 Participants
|
—
|
SECONDARY outcome
Timeframe: Randomization up to data cutoff date (Approximately 48.92 Months)Population: Participants who achieved reduction in transfusion burden response with 4 units minimum starting in the first 24 weeks
Maximum duration of when RBC transfusion dependent subjects who reduce their transfusion burden by ≥ 50% and by ≥ 4 units/12 weeks from baseline over any consecutive 12-week period
Outcome measures
| Measure |
Treatment
n=85 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=24 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Duration of Reduction in Transfusion Burden
|
75.86 Percentage of Participants
Interval 29.86 to 134.86
|
68.86 Percentage of Participants
Interval 23.86 to
The limited number of responders included in the analysis and the high degree of early censoring via KM methodology
|
—
|
SECONDARY outcome
Timeframe: Randomization up to end of blinded treatment period (Approximately 209 Weeks)Population: Intent to Treat Population
Percentage of participants who become RBC-transfusion free over any consecutive 12-week period.
Outcome measures
| Measure |
Treatment
n=208 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
RBC-TI ≥ 12 Weeks in Treatment Period (RBC-TI 12/TP)
|
27.4 Percentage of Participants
|
19.0 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Randomization up to end of blinded treatment period (Approximately 209 Weeks)Population: Intent to Treat Population
Percentage of participants who become RBC-transfusion free over any consecutive 16-week period.
Outcome measures
| Measure |
Treatment
n=208 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
RBC-TI ≥ 16 Weeks in Treatment Period (RBC-TI 16/TP)
|
22.6 Percentage of Participants
|
15.2 Percentage of Participants
|
—
|
SECONDARY outcome
Timeframe: Randomization up to and including Week 24Population: participants who have collected full 24-week transfusion record.
Mean change in transfusion burden (RBC units) from baseline
Outcome measures
| Measure |
Treatment
n=159 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=86 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Change in RBC Transfusion Burden
|
-2.10 Units of RBC
Standard Deviation 3.356
|
-0.50 Units of RBC
Standard Deviation 2.928
|
—
|
SECONDARY outcome
Timeframe: Randomization up to data cutoff date. (Approximately 48.92 months)Population: Participants who achieved at least one RBC-TI 12 weeks starting in the first 24 weeks
Observed cumulative response duration for participants achieving multiple episodes of RBC-TI 12
Outcome measures
| Measure |
Treatment
n=48 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=14 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Observed Cumulative Duration of RBC-transfusion Independence
|
54.86 weeks
Interval 28.36 to 102.29
|
41.50 weeks
Interval 25.0 to 67.0
|
—
|
SECONDARY outcome
Timeframe: Randomization up to week 36 (approximately 36 weeks) and end of treatment (Approximately 209 weeks)Population: Intent to Treat Population
Percentage of participants achieving a mean Hgb increase ≥ 1 g/dL from baseline over any consecutive 12- week period in absence of RBC transfusions
Outcome measures
| Measure |
Treatment
n=208 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Mean Hemoglobin (Hgb) Increase ≥ 1 g/dL
response starting in first 24 weeks
|
15.9 percentage of participants
|
5.7 percentage of participants
|
—
|
|
Mean Hemoglobin (Hgb) Increase ≥ 1 g/dL
response during entire treatment phase
|
22.1 percentage of participants
|
6.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Randomization to Day 169, and to end of treatment (approximately 209 weeks)Population: Intent to Treat Population
Median change in serum ferritin from baseline
Outcome measures
| Measure |
Treatment
n=208 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Median Change in Serum Ferritin From Baseline
To Day 169
|
175.495 ug/L
Interval -2099.0 to 6143.85
|
312.000 ug/L
Interval -863.0 to 3032.0
|
—
|
|
Median Change in Serum Ferritin From Baseline
To end of treatment
|
299.500 ug/L
Interval -554.0 to 1978.0
|
273.000 ug/L
Interval -1338.0 to 1104.0
|
—
|
SECONDARY outcome
Timeframe: First dose up to 42 days post last dose (Approximately 215 weeks)Population: All Treated participants
Frequencies of adverse events according to adverse events categories
Outcome measures
| Measure |
Treatment
n=207 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
n=42 Participants
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Relationship of Adverse Events to Luspatercept and Placebo
at least 1 suspected related Grade 3-4 TEAE
|
19 Participants
|
2 Participants
|
2 Participants
|
|
Relationship of Adverse Events to Luspatercept and Placebo
at least 1 serious TEAE
|
91 Participants
|
40 Participants
|
20 Participants
|
|
Relationship of Adverse Events to Luspatercept and Placebo
at least 1 suspected related serious TEAE
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Relationship of Adverse Events to Luspatercept and Placebo
at least 1 TEAE
|
199 Participants
|
97 Participants
|
36 Participants
|
|
Relationship of Adverse Events to Luspatercept and Placebo
at least 1 suspected related TEAE
|
73 Participants
|
19 Participants
|
14 Participants
|
|
Relationship of Adverse Events to Luspatercept and Placebo
at least 1 grade 3-4 TEAE
|
128 Participants
|
46 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Randomization up to data cutoff date. (Approximately 48.92 months)Population: All Treated participants
Number and percentage of participants who transform to blast phase
Outcome measures
| Measure |
Treatment
n=208 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Transformation to Blast Phase
|
10 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: From randomization up to 48 weeks post first dose (approximately 48 weeks)Population: All treated participants with ADA evaluations
Number of participants with positive or negative ADA Measurement
Outcome measures
| Measure |
Treatment
n=202 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=101 Participants
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Number of Participants With ADA Measurement
Positive ADA
|
10 Participants
|
8 Participants
|
—
|
|
Number of Participants With ADA Measurement
Negative
|
192 Participants
|
93 Participants
|
—
|
SECONDARY outcome
Timeframe: from first dose to day 169Population: PK Population: All treated subjects from the experimental arm with measurable serum concentration data.
Trough Serum concentration of luspatercept at day 169
Outcome measures
| Measure |
Treatment
n=207 Participants
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross Over
Placebo to Luspatercept after day 169
|
|---|---|---|---|
|
Trough Serum Concentration of Luspatercept at Day 169
|
6.36 ug/mL
Standard Deviation 3.71
|
—
|
—
|
Adverse Events
Treatment
Serious events: 91 serious events
Other events: 181 other events
Deaths: 55 deaths
Control
Serious events: 40 serious events
Other events: 79 other events
Deaths: 19 deaths
Cross-over
Serious events: 20 serious events
Other events: 30 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Treatment
n=207 participants at risk
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 participants at risk
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross-over
n=42 participants at risk
Participants receiving treatment in the open label extension period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
4/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
3/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
3/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.4%
3/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Acute left ventricular failure
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Angina unstable
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Arrhythmia
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 flutter
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
BRASH syndrome
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac arrest
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure chronic
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Coronary artery disease
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Palpitations
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Deafness
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
External ear disorder
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Retinal vein thrombosis
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemorrhoidal haemorrhage
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Inguinal hernia
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mesenteric arterial occlusion
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mouth haemorrhage
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Death
|
1.9%
4/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
2/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
General physical health deterioration
|
1.4%
3/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Influenza like illness
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Malaise
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.9%
4/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholangitis
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Abdominal infection
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Appendicitis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Bronchitis
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
2.9%
6/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
3/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19 pneumonia
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cellulitis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Clostridium difficile colitis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Endocarditis
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Epididymitis
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Erysipelas
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia sepsis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Infection
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Influenza
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Legionella infection
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Listeriosis
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Meningitis pneumococcal
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 externa
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pneumococcal infection
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.2%
15/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.6%
8/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
4/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia viral
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pyelonephritis acute
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rhinovirus infection
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Septic shock
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Skin infection
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Splenic abscess
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Staphylococcal sepsis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tuberculosis of central nervous system
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.4%
7/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Urosepsis
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Anaemia postoperative
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Femoral neck fracture
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Femur fracture
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Head injury
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Incarcerated incisional hernia
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pulmonary contusion
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Subdural haematoma
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Subdural haemorrhage
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Blast cell count increased
|
2.4%
5/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
General physical condition abnormal
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mobility decreased
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Torticollis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Acute myeloid leukaemia
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Adenoma benign
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Basal cell carcinoma
|
1.4%
3/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Benign neoplasm of skin
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Bile duct adenocarcinoma
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Blast cell crisis
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Bowen's disease
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Chronic myeloid leukaemia
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Chronic myelomonocytic leukaemia
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Diffuse large B-cell lymphoma
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Lung neoplasm malignant
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 melanoma
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Marginal zone lymphoma
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Meningioma
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Myelofibrosis
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Prostate cancer
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
2/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Squamous cell carcinoma
|
1.9%
4/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Squamous cell carcinoma of lung
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Squamous cell carcinoma of skin
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
2/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Thyroid cancer
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Transformation to acute myeloid leukaemia
|
1.4%
3/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
2/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
2/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypertensive encephalopathy
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Ischaemic stroke
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lacunar infarction
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Sciatica
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Syncope
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Product Issues
Device dislocation
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Renal infarct
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Reproductive system and breast disorders
Pelvic haemorrhage
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bronchopneumopathy
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
1.4%
3/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypersensitivity pneumonitis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Lung disorder
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
2/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 oedema
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Restrictive pulmonary disease
|
0.00%
0/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Arterial disorder
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Deep vein thrombosis
|
1.4%
3/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
2/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.95%
1/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Thrombophlebitis
|
0.48%
1/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Treatment
n=207 participants at risk
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
Control
n=105 participants at risk
Placebo in Blinded Core treatment period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response in Open Label extension period.
|
Cross-over
n=42 participants at risk
Participants receiving treatment in the open label extension period.
Luspatercept, starting dose 1.33 mg/kg that could be up titrated up to 1.75 mg/kg depending on the response.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
3.9%
8/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.7%
6/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
2/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
27.1%
56/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.1%
18/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.0%
8/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.7%
20/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.6%
8/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
2/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.8%
14/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
3/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.0%
31/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.2%
16/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.9%
5/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.2%
19/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
7/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
4/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.7%
16/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
5/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
3/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.6%
22/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
7/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
19.0%
8/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.5%
28/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.7%
7/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Malaise
|
0.97%
2/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
3/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
15.0%
31/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
5/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
6/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.0%
27/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.6%
9/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.9%
5/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
17.9%
37/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.4%
12/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
9/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.7%
6/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.8%
12/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
5/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
2/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.3%
11/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
5/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.2%
19/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.3%
14/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
3/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
7.2%
15/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.8%
4/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
3/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.7%
16/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
3/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.1%
3/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
9.2%
19/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.9%
2/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.3%
13/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.8%
4/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.7%
16/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
5/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
2/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.2%
15/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 overload
|
4.3%
9/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
10/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
10.1%
21/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.5%
11/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
2/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
8.7%
18/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.8%
4/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
4.3%
9/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.7%
6/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
7.7%
16/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
5/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.0%
27/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.8%
4/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
6.8%
14/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.9%
3/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
5.3%
11/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
5/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.4%
1/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
13.0%
27/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.6%
8/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
2/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
11.1%
23/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.6%
8/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
2/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.7%
18/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.8%
4/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
4/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
3.4%
7/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
4/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
17.9%
37/207 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.8%
5/105 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.5%
4/42 • Adverse Events and Serious Adverse Events: First dose up to 42 days post last dose (Approximately 215 weeks). All-Cause mortality: From randomization to latest data cut off point: Approximately 48.92 months
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER