Trial Outcomes & Findings for Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy (NCT NCT02791230)
NCT ID: NCT02791230
Last Updated: 2025-02-03
Results Overview
Time to all-cause mortality was calculated from first dose of randomized treatment in parent study (B3461028) to all-cause mortality events. All-cause mortality events included deaths, heart transplants and cardiac mechanical assist devices implantation treated as death. Treated participants from the parent study who discontinued prior to the start of this study were also included in this analysis as planned. Data from participants who dropped out for a liver-only transplantation were handled in the same manner as the data from all other censored participants. Censored participants were participants who completed study or discontinued from the study (including discontinued by sponsor or participants withdrew, or discontinued due to Adverse event (AE), or alive at the time of analysis. Kaplan Meier method was used for analysis. Therefore, this analysis was based on the pooled dose groups, as per the statistical analysis plan (SAP).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1733 participants
Primary outcome timeframe
From first dose of randomized treatment in parent study (B3461028) up to 28 days post last dose of study treatment in current extension study (B3461045), [approximately up to 91 months]
Results posted on
2025-02-03
Participant Flow
The study consisted of two cohorts: Cohort A and B. Cohort A: Participants diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM) who completed 30 months of participation in parent study \[B3461028 (NCT01994889)\] were enrolled in this current extension study (B3461045 \[NCT02791230\]). Cohort B: Participants diagnosed with ATTR-CM who did not participate in parent study B3461028 study were enrolled in this extension study.
Participant milestones
| Measure |
Cohort A: Tafamidis (Parent and Extension Study)
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 milligrams (mg) or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study)/Tafamidis (Extension Study)
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
170
|
82
|
1481
|
|
Overall Study
Treated
|
170
|
82
|
1476
|
|
Overall Study
COMPLETED
|
84
|
31
|
988
|
|
Overall Study
NOT COMPLETED
|
86
|
51
|
493
|
Reasons for withdrawal
| Measure |
Cohort A: Tafamidis (Parent and Extension Study)
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 milligrams (mg) or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study)/Tafamidis (Extension Study)
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
9
|
66
|
|
Overall Study
Death
|
38
|
25
|
184
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
10
|
|
Overall Study
Failure to Meet Randomization Criteria
|
3
|
2
|
15
|
|
Overall Study
Medication Error Without Associated Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Study sites terminated by sponsor
|
1
|
0
|
5
|
|
Overall Study
Other
|
9
|
1
|
28
|
|
Overall Study
Protocol Violation
|
0
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
24
|
13
|
172
|
|
Overall Study
Enrolled but not treated
|
0
|
0
|
5
|
Baseline Characteristics
Long-term Safety of Tafamidis in Subjects With Transthyretin Cardiomyopathy
Baseline characteristics by cohort
| Measure |
Cohort A: Tafamidis (Parent and Extension Study)
n=170 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study)/Tafamidis (Extension Study)
n=82 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
n=1476 Participants
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
Total
n=1728 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
76.73 Years
STANDARD_DEVIATION 6.75 • n=5 Participants
|
76.41 Years
STANDARD_DEVIATION 6.47 • n=7 Participants
|
76.51 Years
STANDARD_DEVIATION 7.75 • n=5 Participants
|
76.52 Years
STANDARD_DEVIATION 7.60 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
1311 Participants
n=5 Participants
|
1542 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
164 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
1433 Participants
n=5 Participants
|
1678 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
159 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
144 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
1252 Participants
n=5 Participants
|
1468 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose of randomized treatment in parent study (B3461028) up to 28 days post last dose of study treatment in current extension study (B3461045), [approximately up to 91 months]Population: Combined mortality analysis (CMA) set included all participants in the Intent-To-Treat (ITT)-analysis set from study B3461028 (NCT01994889). Mortality analyses in study B3461045 for Cohort A participants included combined data from participants in study B3461028 (NCT01994889), including participants who died, discontinued in B3461028, or were not enrolled into B3461045 (i.e. ITT Analysis Set from B3461028 \[NCT01994889\]) with mortality data through participation in the B3461045 study.
Time to all-cause mortality was calculated from first dose of randomized treatment in parent study (B3461028) to all-cause mortality events. All-cause mortality events included deaths, heart transplants and cardiac mechanical assist devices implantation treated as death. Treated participants from the parent study who discontinued prior to the start of this study were also included in this analysis as planned. Data from participants who dropped out for a liver-only transplantation were handled in the same manner as the data from all other censored participants. Censored participants were participants who completed study or discontinued from the study (including discontinued by sponsor or participants withdrew, or discontinued due to Adverse event (AE), or alive at the time of analysis. Kaplan Meier method was used for analysis. Therefore, this analysis was based on the pooled dose groups, as per the statistical analysis plan (SAP).
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=264 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=177 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Time to All-Cause Mortality: Cohort A
|
58.7 Months
Interval 50.3 to 68.4
|
35.8 Months
Interval 29.7 to 41.1
|
—
|
PRIMARY outcome
Timeframe: B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)Population: Safety analysis population consisted of all participants (Cohort B) who were enrolled in this study and who had taken at least 1 dose of study medication.
All-cause mortality included all participants who had discontinue for transplantation (i.e. heart transplantation and combined heart and liver transplantation) or for implantation of a cardiac mechanical assist device, were handled in the same manner as death. Data from participants who dropped out for a liver-only transplantation were handled in the same manner as the data from all other censored participants. Censored participants were participants who completed study or discontinued from the study (including discontinued by sponsor or participants withdrew, or discontinued due to AE), or alive at the time of analysis. Kaplan Meier method was used for analysis.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=1476 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Number of Participants With All-Cause Mortality Events: Cohort B
|
345 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)Population: Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
An AE was any untoward medical occurrence in a participant who received investigational product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and all Non-SAEs. A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect; considered an important medical event.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=170 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=82 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
n=1476 Participants
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs)
|
168 Participants
|
79 Participants
|
1294 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first dose of randomized treatment in parent study (B3461028) up to 28 days post last dose of study treatment in current extension study (B3461045), [approximately up to 91 months]Population: CMA set included all participants in the ITT analysis set from study B3461028 (NCT01994889). Mortality analyses in study B3461045 for Cohort A participants were combined data from participants in study B3461028 (NCT01994889), including participants who died, discontinued in B3461028, or were not enrolled into B3461045 (i.e. ITT Analysis Set from B3461028 \[NCT01994889\]) with mortality data through participation in the B3461045 study.
Time to cardiovascular-related mortality was calculated from first dose of randomized treatment in B3461028 . Participants who discontinued for transplantation (that is heart transplantation and combined heart and liver transplantation) or for implantation of cardiac mechanical assist device were treated as a death. Treated participants from the parent study who discontinued prior to the start of this study were also included in this analysis as planned. Kaplan-Meier method was used. Therefore, this analysis was based on the pooled dose groups, as per the SAP.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=264 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=177 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Time to Cardiovascular-Related Mortality Events: Cohort A
|
70.2 Months
Interval 63.4 to 88.8
|
40.8 Months
Interval 34.1 to 50.7
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)Population: Safety analysis population included all participants who were enrolled in this study and taken at least 1 dose of study medication.
Deaths adjudicated as cardiovascular-related and indeterminate were reported. Cardiovascular-related mortality events included deaths, heart transplants and cardiac mechanical assist devices implantation treated as death. Cardiovascular relatedness was based on clinical judgement.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=1476 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Number of Participants With Cardiovascular Related Mortality Events: Cohort B
|
204 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)Population: Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
Mean annual rate of all cause hospitalization was calculated for each participant as the participant's number of all cause hospitalizations divided by this participant's duration on study in years. Hospitalization was defined as any initial admission (even less than 24 hours) in a hospital or equivalent healthcare facility or any prolongation of an existing admission. Only all cause hospitalizations where the participant was admitted to a hospital during the current extension study were included in this analysis. Any hospitalizations prior to randomization date were not included.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=170 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=82 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
n=1476 Participants
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Mean Annualized Rate of All Cause Hospitalizations
|
1.67 Hospitalization/year
Standard Deviation 5.830
|
1.84 Hospitalization/year
Standard Deviation 2.275
|
0.96 Hospitalization/year
Standard Deviation 5.117
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)Population: Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
Mean annual rate of CV related hospitalization was calculated for each participant as the participant's number of CV related hospitalizations divided by this participant's duration on study in years. CV-related hospitalizations included hospitalizations due to heart failure, arrhythmia, myocardial infarction, stroke, and other cardiovascular-related events. Hospitalization was defined as any initial admission (even less than 24 hours) in a hospital or equivalent healthcare facility or any prolongation of an existing admission. Admission also included transfer within the hospital to an acute/intensive care unit (example: from the psychiatric wing to a medical floor, medical floor to a coronary care unit, or neurological floor to a tuberculosis unit).
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=170 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=82 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
n=1476 Participants
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Mean Annualized Rate of Cardiovascular (CV)-Related Hospitalizations
|
1.09 CV related hospitalization/year
Standard Deviation 5.409
|
1.14 CV related hospitalization/year
Standard Deviation 1.899
|
0.50 CV related hospitalization/year
Standard Deviation 1.567
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461028: Baseline (Day 1, pre-dose), Months 12, 30; B3461045: Months 42, 60 and 90 (time points were relative to Day 1 from B3461028; 42, 60 and 90 Months were 12, 30 and 60 Months of B3461045)Population: CMA set was analyzed. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified time points. Therefore, this analysis was based on the pooled dose groups, as per the SAP.
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-clinical summary score was calculated as mean of the following domains- physical limitation and total symptoms and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as least square (LS) mean.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=264 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=177 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A
Change at Month 12
|
-3.17 Units on a scale
Standard Error 1.016
|
-10.2 Units on a scale
Standard Error 1.316
|
—
|
|
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A
Change at Month 30
|
-7.41 Units on a scale
Standard Error 1.185
|
-19.9 Units on a scale
Standard Error 1.999
|
—
|
|
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A
Change at Month 42
|
-11.2 Units on a scale
Standard Error 1.483
|
-25.4 Units on a scale
Standard Error 2.143
|
—
|
|
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A
Change at Month 60
|
-11.8 Units on a scale
Standard Error 1.756
|
-25.1 Units on a scale
Standard Error 3.287
|
—
|
|
Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Scores at Months 12, 30, 42, 60 and 90: Cohort A
Change at Month 90
|
-17.4 Units on a scale
Standard Error 2.758
|
-56.9 Units on a scale
Standard Error 1.868
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461028: Baseline (Day 1, pre-dose), Months 12, 30; B3461045: Months 42, 60 and 90 (time points were relative to Day 1 from B3461028; 42, 60 and 90 Months were 12, 30 and 60 Months of B3461045)Population: CMA set was analyzed. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified time points. Therefore, this analysis was based on the pooled dose groups, as per the SAP.
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-overall score was calculated as mean of the following domains- physical limitation, total symptoms (average of symptom frequency \& symptom burden), quality of life, social limitation and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as LS mean.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=264 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=177 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A
Change at Month 12
|
-1.97 Units on a scale
Standard Error 1.131
|
-9.69 Units on a scale
Standard Error 1.428
|
—
|
|
Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A
Change at Month 30
|
-6.07 Units on a scale
Standard Error 1.399
|
-19.5 Units on a scale
Standard Error 1.908
|
—
|
|
Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A
Change at Month 42
|
-8.81 Units on a scale
Standard Error 1.470
|
-24.0 Units on a scale
Standard Error 2.114
|
—
|
|
Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A
Change at Month 60
|
-8.56 Units on a scale
Standard Error 1.646
|
-24.5 Units on a scale
Standard Error 3.020
|
—
|
|
Change From Baseline in KCCQ Overall Score at Months 12, 30, 42, 60, 90: Cohort A
Change at Month 90
|
-18.1 Units on a scale
Standard Error 2.617
|
-52.6 Units on a scale
Standard Error 1.791
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461028: Baseline (Day 1, pre-dose), Months 12, 30; B3461045: Months 42, 60 and 90 (time points were relative to Day 1 from B3461028; 42, 60 and 90 Months were 12, 30 and 60 Months of B3461045)Population: CMA set was analyzed. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified time points. Therefore, this analysis was based on the pooled dose groups, as per the SAP.
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ Total Symptoms score was calculated as mean of the following domains- symptom frequency and symptom burden and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as LS mean.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=264 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=177 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A
Change at Month 12
|
-2.90 Units on a scale
Standard Error 1.182
|
-10.3 Units on a scale
Standard Error 1.494
|
—
|
|
Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A
Change at Month 30
|
-5.92 Units on a scale
Standard Error 1.279
|
-18.7 Units on a scale
Standard Error 2.276
|
—
|
|
Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A
Change at Month 42
|
-9.29 Units on a scale
Standard Error 1.699
|
-22.5 Units on a scale
Standard Error 2.237
|
—
|
|
Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A
Change at Month 60
|
-8.94 Units on a scale
Standard Error 1.858
|
-19.0 Units on a scale
Standard Error 3.693
|
—
|
|
Change From Baseline in KCCQ Total Symptom Score at Months 12, 30, 42, 60 and 90: Cohort A
Change at Month 90
|
-16.4 Units on a scale
Standard Error 2.654
|
-56.0 Units on a scale
Standard Error 1.958
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461045: Baseline (Day 1, pre-dose), Months 12, 30 and 54Population: Safety analysis population included all participants (Cohort B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified time points.
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-clinical summary score was calculated as mean of the following domains- physical limitation and total symptoms and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as mean.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=830 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Change From Baseline in KCCQ Clinical Summary Scores at Months 12, 30 and 54: Cohort B
Change at Month 12
|
-0.242 Units on a scale
Standard Deviation 17.7032
|
—
|
—
|
|
Change From Baseline in KCCQ Clinical Summary Scores at Months 12, 30 and 54: Cohort B
Change at Month 30
|
-3.086 Units on a scale
Standard Deviation 20.4276
|
—
|
—
|
|
Change From Baseline in KCCQ Clinical Summary Scores at Months 12, 30 and 54: Cohort B
Change at Month 54
|
-3.988 Units on a scale
Standard Deviation 18.7931
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461045: Baseline (Day 1, pre-dose), Months 12, 30 and 54Population: Safety analysis population included all participants (Cohort B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified time points.
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ-overall score was calculated as mean of the following domains- physical limitation, total symptoms (average of symptom frequency \& symptom burden), quality of life, social limitation and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as mean.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=830 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Change From Baseline in KCCQ Overall Score at Months 12, 30 and 54: Cohort B
Change at Month 12
|
0.443 Units on a scale
Standard Deviation 18.2575
|
—
|
—
|
|
Change From Baseline in KCCQ Overall Score at Months 12, 30 and 54: Cohort B
Change at Month 30
|
-1.378 Units on a scale
Standard Deviation 20.9437
|
—
|
—
|
|
Change From Baseline in KCCQ Overall Score at Months 12, 30 and 54: Cohort B
Change at Month 54
|
-2.093 Units on a scale
Standard Deviation 19.5085
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461045: Baseline (Day 1, pre-dose), Months 12, 30 and 54Population: Safety analysis population included all participants (Cohort B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified time points.
KCCQ: 23-item, self-administered questionnaire that assesses health status and health-related quality of life in participants with heart failure. KCCQ quantifies 8 domains: physical limitations, symptom stability, symptom frequency, symptom burden, total symptom (mean of symptom frequency and symptom burden), self-efficacy, quality of life and social limitations). Scores were generated for each domain and scaled from 0 (worst) to 100 (best possible status). KCCQ Total Symptoms score was calculated as mean of the following domains- symptom frequency and symptom burden and transformed to a single score which ranged from 0 (worst) -100 (best possible status), higher scores = better health status. Data for change from baseline was reported as mean.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=829 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Change From Baseline in KCCQ Total Symptom Score at Months 12, 30 and 54: Cohort B
Change at Month 12
|
0.738 Units on a scale
Standard Deviation 19.1549
|
—
|
—
|
|
Change From Baseline in KCCQ Total Symptom Score at Months 12, 30 and 54: Cohort B
Change at Month 30
|
-1.112 Units on a scale
Standard Deviation 20.7952
|
—
|
—
|
|
Change From Baseline in KCCQ Total Symptom Score at Months 12, 30 and 54: Cohort B
Change at Month 54
|
-1.885 Units on a scale
Standard Deviation 19.4433
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60Population: Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified time points. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
NYHA classification: Class I: Participants with cardiovascular disease (CVD) but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain; Class II: Participants with CVD resulting in slight limitation of physical activity and were comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina pain; Class III: participants with CVD resulting in marked limitation of physical activity and were comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain; Class IV: participants with CVD resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity was undertaken, discomfort was increased.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=170 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=82 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
n=1476 Participants
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class II (Baseline) to Class I
|
6 Participants
|
0 Participants
|
50 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class II (Baseline) to Class I
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class II (Baseline) to Class II
|
7 Participants
|
3 Participants
|
22 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class I (Baseline) to Class I
|
13 Participants
|
4 Participants
|
132 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class I (Baseline) to Class II
|
4 Participants
|
2 Participants
|
70 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class I (Baseline) to Class III
|
0 Participants
|
0 Participants
|
8 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class I (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class II (Baseline) to Class I
|
7 Participants
|
0 Participants
|
60 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class II (Baseline) to Class II
|
65 Participants
|
20 Participants
|
542 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class II (Baseline) to Class III
|
11 Participants
|
2 Participants
|
100 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class II (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class III (Baseline) to Class I
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class III (Baseline) to Class II
|
17 Participants
|
9 Participants
|
88 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class III (Baseline) to Class III
|
34 Participants
|
24 Participants
|
226 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class III (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class IV (Baseline) to Class I
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class IV (Baseline) to Class II
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class IV (Baseline) to Class III
|
1 Participants
|
3 Participants
|
10 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 6 · Class IV (Baseline) to Class IV
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class I (Baseline) to Class I
|
10 Participants
|
4 Participants
|
94 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class I (Baseline) to Class II
|
5 Participants
|
0 Participants
|
60 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class I (Baseline) to Class III
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class I (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class II (Baseline) to Class II
|
63 Participants
|
16 Participants
|
371 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class II (Baseline) to Class III
|
10 Participants
|
1 Participants
|
67 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class II (Baseline) to Class IV
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class III (Baseline) to Class I
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class III (Baseline) to Class II
|
12 Participants
|
9 Participants
|
67 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class III (Baseline) to Class III
|
31 Participants
|
23 Participants
|
127 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class III (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class IV (Baseline) to Class I
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class IV (Baseline) to Class II
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class IV (Baseline) to Class III
|
0 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 12 · Class IV (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class I (Baseline) to Class I
|
5 Participants
|
4 Participants
|
64 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class I (Baseline) to Class II
|
3 Participants
|
0 Participants
|
45 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class I (Baseline) to Class III
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class I (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class II (Baseline) to Class I
|
8 Participants
|
0 Participants
|
41 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class II (Baseline) to Class II
|
49 Participants
|
15 Participants
|
259 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class II (Baseline) to Class III
|
9 Participants
|
1 Participants
|
61 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class II (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class III (Baseline) to Class I
|
2 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class III (Baseline) to Class II
|
19 Participants
|
6 Participants
|
57 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class III (Baseline) to Class III
|
24 Participants
|
19 Participants
|
70 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class III (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class IV (Baseline) to Class I
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class IV (Baseline) to Class II
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class IV (Baseline) to Class III
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 18 · Class IV (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class I (Baseline) to Class I
|
4 Participants
|
4 Participants
|
42 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class I (Baseline) to Class II
|
4 Participants
|
1 Participants
|
40 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class I (Baseline) to Class III
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class I (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class II (Baseline) to Class I
|
8 Participants
|
0 Participants
|
31 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class II (Baseline) to Class II
|
49 Participants
|
12 Participants
|
191 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class II (Baseline) to Class III
|
3 Participants
|
0 Participants
|
42 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class II (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class III (Baseline) to Class I
|
4 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class III (Baseline) to Class II
|
11 Participants
|
8 Participants
|
34 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class III (Baseline) to Class III
|
17 Participants
|
14 Participants
|
46 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class IV (Baseline) to Class III
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class III (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class IV (Baseline) to Class I
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class IV (Baseline) to Class II
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 24 · Class IV (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class I (Baseline) to Class I
|
1 Participants
|
1 Participants
|
27 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class I (Baseline) to Class II
|
1 Participants
|
0 Participants
|
32 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class I (Baseline) to Class III
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class I (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class II (Baseline) to Class I
|
5 Participants
|
1 Participants
|
26 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class II (Baseline) to Class II
|
27 Participants
|
7 Participants
|
129 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class II (Baseline) to Class III
|
2 Participants
|
1 Participants
|
24 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class II (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class III (Baseline) to Class I
|
4 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class III (Baseline) to Class II
|
14 Participants
|
4 Participants
|
22 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class III (Baseline) to Class III
|
10 Participants
|
9 Participants
|
24 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class III (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class IV (Baseline) to Class I
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class IV (Baseline) to Class II
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class IV (Baseline) to Class III
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 30 · Class IV (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class I (Baseline) to Class I
|
1 Participants
|
2 Participants
|
21 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class I (Baseline) to Class II
|
4 Participants
|
0 Participants
|
18 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class I (Baseline) to Class III
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class I (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class II (Baseline) to Class I
|
3 Participants
|
0 Participants
|
19 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class II (Baseline) to Class II
|
19 Participants
|
7 Participants
|
101 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class II (Baseline) to Class III
|
2 Participants
|
1 Participants
|
25 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class II (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class III (Baseline) to Class I
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class III (Baseline) to Class II
|
5 Participants
|
2 Participants
|
21 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class III (Baseline) to Class III
|
7 Participants
|
4 Participants
|
14 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class III (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class IV (Baseline) to Class I
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class IV (Baseline) to Class II
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class IV (Baseline) to Class III
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 36 · Class IV (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class I (Baseline) to Class I
|
0 Participants
|
0 Participants
|
16 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class I (Baseline) to Class II
|
3 Participants
|
1 Participants
|
11 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class I (Baseline) to Class III
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class I (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class II (Baseline) to Class I
|
4 Participants
|
1 Participants
|
9 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class II (Baseline) to Class II
|
14 Participants
|
4 Participants
|
77 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class II (Baseline) to Class III
|
2 Participants
|
0 Participants
|
16 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class II (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class III (Baseline) to Class I
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class III (Baseline) to Class II
|
3 Participants
|
1 Participants
|
20 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class III (Baseline) to Class III
|
4 Participants
|
1 Participants
|
12 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class III (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class IV (Baseline) to Class I
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class IV (Baseline) to Class II
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class IV (Baseline) to Class III
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 42 · Class IV (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class I (Baseline) to Class I
|
0 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class I (Baseline) to Class II
|
2 Participants
|
0 Participants
|
8 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class I (Baseline) to Class III
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class I (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class II (Baseline) to Class I
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class II (Baseline) to Class II
|
12 Participants
|
4 Participants
|
54 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class II (Baseline) to Class III
|
2 Participants
|
0 Participants
|
7 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class II (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class III (Baseline) to Class I
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class III (Baseline) to Class II
|
3 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class III (Baseline) to Class III
|
4 Participants
|
1 Participants
|
13 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class III (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class IV (Baseline) to Class I
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class IV (Baseline) to Class II
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class IV (Baseline) to Class III
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 48 · Class IV (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class I (Baseline) to Class I
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class I (Baseline) to Class II
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class I (Baseline) to Class III
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class I (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class III (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class IV (Baseline) to Class I
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class IV (Baseline) to Class II
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class IV (Baseline) to Class III
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class IV (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class I (Baseline) to Class I
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class I (Baseline) to Class II
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class I (Baseline) to Class III
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class I (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class II (Baseline) to Class I
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class II (Baseline) to Class II
|
4 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class II (Baseline) to Class III
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class II (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class III (Baseline) to Class I
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class III (Baseline) to Class II
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class III (Baseline) to Class III
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class III (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class IV (Baseline) to Class I
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class IV (Baseline) to Class II
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class IV (Baseline) to Class III
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 60 · Class IV (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class II (Baseline) to Class III
|
2 Participants
|
0 Participants
|
6 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class II (Baseline) to Class IV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class III (Baseline) to Class I
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class III (Baseline) to Class II
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Shift From Baseline in New York Heart Association (NYHA) Classification at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Month 54 · Class III (Baseline) to Class III
|
3 Participants
|
0 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60Population: Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified time points. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
BMI was calculated as: body weight in kilogram (kg) divided by (/) square of body height measurement in meters square (m\^2).
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=170 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=82 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
n=1476 Participants
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 6
|
-0.07 kg/m^2
Standard Deviation 0.873
|
-0.27 kg/m^2
Standard Deviation 0.900
|
-0.24 kg/m^2
Standard Deviation 1.234
|
|
Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 12
|
-0.21 kg/m^2
Standard Deviation 1.212
|
-0.40 kg/m^2
Standard Deviation 1.440
|
-0.20 kg/m^2
Standard Deviation 1.552
|
|
Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 18
|
-0.38 kg/m^2
Standard Deviation 1.442
|
-0.85 kg/m^2
Standard Deviation 1.502
|
-0.30 kg/m^2
Standard Deviation 1.956
|
|
Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 24
|
-0.36 kg/m^2
Standard Deviation 1.407
|
-0.78 kg/m^2
Standard Deviation 1.668
|
-0.43 kg/m^2
Standard Deviation 1.747
|
|
Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 30
|
-0.71 kg/m^2
Standard Deviation 1.423
|
-1.28 kg/m^2
Standard Deviation 1.814
|
-0.41 kg/m^2
Standard Deviation 1.802
|
|
Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 36
|
-1.18 kg/m^2
Standard Deviation 2.200
|
-0.49 kg/m^2
Standard Deviation 1.852
|
-0.69 kg/m^2
Standard Deviation 1.730
|
|
Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 42
|
-0.91 kg/m^2
Standard Deviation 1.402
|
-0.11 kg/m^2
Standard Deviation 1.523
|
-0.74 kg/m^2
Standard Deviation 1.827
|
|
Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 48
|
-1.14 kg/m^2
Standard Deviation 1.480
|
-0.01 kg/m^2
Standard Deviation 1.927
|
-0.83 kg/m^2
Standard Deviation 1.732
|
|
Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 54
|
-1.03 kg/m^2
Standard Deviation 1.716
|
-1.54 kg/m^2
Standard Deviation 0.528
|
-1.24 kg/m^2
Standard Deviation 1.942
|
|
Change From Baseline in Body Mass Index (BMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 60
|
-0.93 kg/m^2
Standard Deviation 2.102
|
-1.62 kg/m^2
Standard Deviation 0.834
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60Population: Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies number of participants evaluable at specified time points. Therefore, this analysis (Cohort A) was based on the pooled dose groups, as per the SAP.
Modified (m)BMI of participants was calculated to determine if there was any gastrointestinal involvement in participants. The mBMI was calculated by multiplying BMI by serum albumin concentration gram/liter (g/L).
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=170 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=82 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
n=1476 Participants
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 6
|
-2.96 (kg/m^2) *(g/L)
Standard Deviation 36.046
|
-10.91 (kg/m^2) *(g/L)
Standard Deviation 36.338
|
-8.51 (kg/m^2) *(g/L)
Standard Deviation 51.329
|
|
Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 12
|
-7.42 (kg/m^2) *(g/L)
Standard Deviation 49.840
|
-16.09 (kg/m^2) *(g/L)
Standard Deviation 57.882
|
-6.17 (kg/m^2) *(g/L)
Standard Deviation 66.094
|
|
Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 18
|
-15.46 (kg/m^2) *(g/L)
Standard Deviation 60.361
|
-35.46 (kg/m^2) *(g/L)
Standard Deviation 63.390
|
-10.08 (kg/m^2) *(g/L)
Standard Deviation 85.605
|
|
Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 24
|
-15.07 (kg/m^2) *(g/L)
Standard Deviation 58.706
|
-32.33 (kg/m^2) *(g/L)
Standard Deviation 71.104
|
-15.81 (kg/m^2) *(g/L)
Standard Deviation 74.009
|
|
Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 30
|
-29.31 (kg/m^2) *(g/L)
Standard Deviation 61.003
|
-52.81 (kg/m^2) *(g/L)
Standard Deviation 78.705
|
-15.70 (kg/m^2) *(g/L)
Standard Deviation 79.724
|
|
Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 36
|
-49.46 (kg/m^2) *(g/L)
Standard Deviation 98.257
|
-17.81 (kg/m^2) *(g/L)
Standard Deviation 80.327
|
-24.66 (kg/m^2) *(g/L)
Standard Deviation 74.366
|
|
Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 42
|
-36.32 (kg/m^2) *(g/L)
Standard Deviation 58.130
|
1.59 (kg/m^2) *(g/L)
Standard Deviation 69.701
|
-28.06 (kg/m^2) *(g/L)
Standard Deviation 78.987
|
|
Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 48
|
-46.43 (kg/m^2) *(g/L)
Standard Deviation 62.394
|
14.05 (kg/m^2) *(g/L)
Standard Deviation 83.969
|
-32.91 (kg/m^2) *(g/L)
Standard Deviation 71.745
|
|
Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 54
|
-41.98 (kg/m^2) *(g/L)
Standard Deviation 74.883
|
-52.80 (kg/m^2) *(g/L)
Standard Deviation 14.562
|
-51.15 (kg/m^2) *(g/L)
Standard Deviation 79.618
|
|
Change From Baseline in Modified Body Mass Index (mBMI) at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 60
|
-38.90 (kg/m^2) *(g/L)
Standard Deviation 92.253
|
-41.20 (kg/m^2) *(g/L)
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60Population: Analysis was performed using Safety analysis population."Number of Participants Analyzed"=number of participants evaluable.All participants reported under"Number of Participants Analyzed"contributed data to the table;however,may not have evaluable data for every row."Number Analyzed"=number of participants evaluable at specified time points.The measurement was not required for participants enrolled before Protocol Amendment4(PA-4).The analysis(Cohort A)was based on pooled dose groups,as per SAP.
Troponin I is the cardiac markers. Higher level of the marker was indicative of heart damage. It was measure in nanogram per milliliter (ng/mL). Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=170 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=82 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
n=495 Participants
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 60
|
-0.040 ng/mL
Standard Deviation 0.0414
|
0.035 ng/mL
Standard Deviation 0.0354
|
—
|
|
Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 6
|
—
|
—
|
0.012 ng/mL
Standard Deviation 0.1706
|
|
Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 12
|
0.035 ng/mL
Standard Deviation 0.3977
|
0.037 ng/mL
Standard Deviation 0.0853
|
0.009 ng/mL
Standard Deviation 0.0893
|
|
Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 18
|
0.040 ng/mL
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
—
|
-0.007 ng/mL
Standard Deviation 0.0786
|
|
Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 24
|
0.000 ng/mL
Standard Deviation 0.0566
|
0.033 ng/mL
Standard Deviation 0.0306
|
-0.031 ng/mL
Standard Deviation 0.2031
|
|
Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 30
|
0.022 ng/mL
Standard Deviation 0.1599
|
0.100 ng/mL
Standard Deviation 0.1728
|
-0.033 ng/mL
Standard Deviation 0.2055
|
|
Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 36
|
0.009 ng/mL
Standard Deviation 0.0579
|
0.018 ng/mL
Standard Deviation 0.1057
|
-0.034 ng/mL
Standard Deviation 0.1913
|
|
Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 42
|
-0.002 ng/mL
Standard Deviation 0.0795
|
-0.047 ng/mL
Standard Deviation 0.0755
|
-0.021 ng/mL
Standard Deviation 0.2484
|
|
Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 48
|
0.016 ng/mL
Standard Deviation 0.0795
|
-0.067 ng/mL
Standard Deviation 0.2040
|
-0.100 ng/mL
Standard Deviation 0.0000
|
|
Change From Baseline in Troponin I Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 54
|
-0.033 ng/mL
Standard Deviation 0.0792
|
-0.363 ng/mL
Standard Deviation 0.6080
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: B3461045: Baseline (Day 1, pre-dose), Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60Population: Analysis was performed using Safety analysis population. "Number of Participants Analyzed"= number of participants evaluable. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed"= number of participants evaluable at specified time points. This measurement was not required for participants enrolled before PA-4. This analysis (Cohort A) was based on pooled dose groups, as per SAP.
NT-proBNP was a cardiac marker which had the prognostic value for participants with heart failure or left ventricular dysfunction. It was measure in picomole per liter (pmole/L). Higher level of the marker was indicative of heart damage. Safety analysis population included all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
Outcome measures
| Measure |
Cohort A: Tafamidis (Parent Study) and Tafamidis (Extension Study)
n=170 Participants
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study) and Tafamidis (Extension Study)
n=82 Participants
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
n=516 Participants
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 6
|
—
|
—
|
24.820 pmole/L
Standard Deviation 171.2075
|
|
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 12
|
31.117 pmole/L
Standard Deviation 220.9279
|
127.973 pmole/L
Standard Deviation 226.7727
|
32.686 pmole/L
Standard Deviation 180.4921
|
|
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 18
|
226.442 pmole/L
Standard Deviation NA
Standard deviation could not be calculated as only one participant was analyzed.
|
—
|
71.582 pmole/L
Standard Deviation 329.5411
|
|
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 24
|
131.334 pmole/L
Standard Deviation 119.5258
|
256.442 pmole/L
Standard Deviation 101.8073
|
92.899 pmole/L
Standard Deviation 320.6054
|
|
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 30
|
159.596 pmole/L
Standard Deviation 404.8483
|
417.682 pmole/L
Standard Deviation 597.9224
|
149.049 pmole/L
Standard Deviation 320.8814
|
|
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 36
|
322.963 pmole/L
Standard Deviation 215.1605
|
420.196 pmole/L
Standard Deviation 251.8446
|
88.895 pmole/L
Standard Deviation 227.7375
|
|
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 42
|
419.034 pmole/L
Standard Deviation 315.6436
|
324.211 pmole/L
Standard Deviation 173.6652
|
191.318 pmole/L
Standard Deviation 482.3582
|
|
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 48
|
492.154 pmole/L
Standard Deviation 387.4700
|
400.571 pmole/L
Standard Deviation 228.4343
|
264.566 pmole/L
Standard Deviation 78.7059
|
|
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 54
|
405.887 pmole/L
Standard Deviation 457.6349
|
340.082 pmole/L
Standard Deviation 190.6412
|
—
|
|
Change From Baseline in N-Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP) Concentration at Months 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60
Change at Month 60
|
392.363 pmole/L
Standard Deviation 271.2883
|
314.184 pmole/L
Standard Deviation 274.6756
|
—
|
Adverse Events
Cohort A: Tafamidis (Parent and Extension Study)
Serious events: 132 serious events
Other events: 152 other events
Deaths: 45 deaths
Cohort A: Placebo (Parent Study)/Tafamidis (Extension Study)
Serious events: 64 serious events
Other events: 76 other events
Deaths: 33 deaths
Cohort B: Tafamidis (Only in Extension Study)
Serious events: 736 serious events
Other events: 1023 other events
Deaths: 203 deaths
Serious adverse events
| Measure |
Cohort A: Tafamidis (Parent and Extension Study)
n=170 participants at risk
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study)/Tafamidis (Extension Study)
n=82 participants at risk
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
n=1476 participants at risk
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
17/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Deficiency anaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Acute left ventricular failure
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
3/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Angina pectoris
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.75%
11/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Angina unstable
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Arrhythmia
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
6.5%
11/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
9.8%
8/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.2%
62/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial flutter
|
2.4%
4/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
18/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Atrioventricular block
|
2.4%
4/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.54%
8/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.1%
16/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Bifascicular block
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Bradycardia
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.75%
11/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Bundle branch block bilateral
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac amyloidosis
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.1%
16/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
3.5%
6/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
3/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.95%
14/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
17.6%
30/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
20.7%
17/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
11.4%
169/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure acute
|
7.6%
13/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
12.2%
10/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.3%
48/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.9%
4/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.68%
10/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
10.0%
17/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
17.1%
14/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.5%
52/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac flutter
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardio-respiratory distress
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiogenic shock
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.4%
20/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiomyopathy
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
3/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Coronary artery disease
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Coronary artery embolism
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Left ventricular failure
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.41%
6/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Pericardial effusion
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Sinoatrial block
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Sinus arrest
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.68%
10/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.3%
6/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
17/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Congenital, familial and genetic disorders
Familial amyloidosis
|
2.4%
4/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.68%
10/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Congenital, familial and genetic disorders
Hereditary neuropathic amyloidosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Ear and labyrinth disorders
Vertigo
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Eye disorders
Cataract
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Eye disorders
Charles Bonnet syndrome
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Eye disorders
Orbital haematoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Eye disorders
Vision blurred
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Eye disorders
Vitreous haemorrhage
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.41%
6/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Appendiceal mucocoele
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.54%
8/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Faecaloma
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.4%
4/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.88%
13/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Melaena
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Mesenteric vascular insufficiency
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.41%
6/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
2.4%
4/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Death
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Discomfort
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Disease progression
|
2.4%
4/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
3/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.5%
22/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
General physical health deterioration
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.75%
11/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Generalised oedema
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Hernia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Hypothermia
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Implant site haematoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Inflammation
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Multi-organ disorder
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.41%
6/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Pain
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Peripheral swelling
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Sudden death
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.41%
6/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Systemic inflammatory response syndrome
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cardiac cirrhosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Congestive hepatopathy
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Immune system disorders
Acquired ATTR amyloidosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Immune system disorders
Amyloidosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Immune system disorders
Primary amyloidosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Arthritis bacterial
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis viral
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
COVID-19
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.1%
16/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.61%
9/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Cardiac infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
4.7%
8/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
18/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Device related infection
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Endophthalmitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Erysipelas
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Escherichia sepsis
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Herpes zoster meningoencephalitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Herpes zoster meningomyelitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Implant site infection
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Legionella infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Localised infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Meningitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Osteomyelitis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pericarditis infective
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Peritonsillar abscess
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
7.1%
12/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
11.0%
9/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.6%
39/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia aspiration
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia bacterial
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia pneumococcal
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pyelonephritis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory moniliasis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Scrotal cellulitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
4.7%
8/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.9%
4/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
17/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.68%
10/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcal infection
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Superinfection fungal
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
17/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Urosepsis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Viral infection
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Complications of transplanted kidney
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
5.9%
10/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.7%
25/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fat embolism
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.61%
9/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Ilium fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Periprosthetic osteolysis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.68%
10/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Vasoplegia syndrome
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Apnoea test
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Blood potassium abnormal
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Blood urea increased
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Bronchial aspiration procedure
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Ejection fraction
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Heart rate irregular
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Peritoneal fluid analysis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Troponin increased
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Gout
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.61%
9/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.54%
8/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.54%
8/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.61%
9/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.61%
9/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Immunoglobulin G4 related disease
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.61%
9/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.61%
9/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system melanoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hormone-dependent prostate cancer
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome with excess blasts
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IIIB
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncocytoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primary pulmonary melanoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.41%
6/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Brain compression
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Brain injury
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral ischaemia
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
3/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
17/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.41%
6/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Coma
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Dementia
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Embolic stroke
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Encephalopathy
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Hemianopia
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Hemianopia homonymous
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
3/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.75%
11/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Loss of consciousness
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Polyneuropathy
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Seizure
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Somnolence
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
3.5%
6/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.8%
42/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.61%
9/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Product Issues
Device capturing issue
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Product Issues
Device dislocation
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Product Issues
Device failure
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Product Issues
Device inappropriate shock delivery
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Product Issues
Device loosening
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Product Issues
Device malfunction
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Product Issues
Device occlusion
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Completed suicide
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.41%
6/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Mental status changes
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
9.4%
16/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
15.9%
13/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.3%
34/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
End stage renal disease
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
3/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.54%
8/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal pseudoaneurysm
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary retention
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Breast pain
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.88%
13/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.34%
5/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.9%
4/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.68%
10/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary amyloidosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.27%
4/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.47%
7/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.81%
12/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Cellulite
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Surgical and medical procedures
Cardiac ablation
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Surgical and medical procedures
Muscle electrostimulation therapy
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Surgical and medical procedures
Therapy change
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Surgical and medical procedures
Wound treatment
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.68%
10/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Arteriovenous fistula
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Axillary vein thrombosis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Distributive shock
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Embolism
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Haematoma
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.9%
4/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.1%
16/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Iliac artery stenosis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Ischaemic limb pain
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.20%
3/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral vein stenosis
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Shock
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Shock haemorrhagic
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Thrombosis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.07%
1/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Venous thrombosis limb
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.00%
0/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
Other adverse events
| Measure |
Cohort A: Tafamidis (Parent and Extension Study)
n=170 participants at risk
Eligible participants who received tafamidis in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort A: Placebo (Parent Study)/Tafamidis (Extension Study)
n=82 participants at risk
Eligible participants who received placebo in the parent study, after enrolment in the current extension study continued to receive tafamidis 61 mg or 80 mg (in regions where 61 mg tafamidis was unavailable), orally once daily along with standard of care for up to 60 months.
|
Cohort B: Tafamidis (Only in Extension Study)
n=1476 participants at risk
Participants who did not participate in the parent study and received tafamidis at a dose of 61 mg (or 80 mg in regions where 61 mg tafamidis was unavailable), once daily along with standard of care for up to 60 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.2%
14/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
14.6%
12/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
5.3%
78/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.14%
2/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
18.8%
32/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
20.7%
17/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
10.2%
150/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
12.9%
22/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
11.0%
9/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
11.3%
167/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Pericardial effusion
|
3.5%
6/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.3%
6/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.54%
8/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Cardiac disorders
Ventricular tachycardia
|
5.9%
10/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
11.0%
9/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.4%
20/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Eye disorders
Cataract
|
5.9%
10/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.2%
1/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.6%
24/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.9%
5/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.4%
20/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
5.3%
9/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.9%
4/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.3%
19/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
10.6%
18/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
18.3%
15/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.9%
117/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
15/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
9.8%
8/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.6%
97/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
11/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
8.5%
7/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.0%
29/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
17/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
12.2%
10/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.3%
48/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
10/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
8.5%
7/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.0%
30/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
7.6%
13/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
14.6%
12/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
54/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
11.2%
19/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
18.3%
15/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
5.3%
78/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Gait disturbance
|
2.9%
5/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.3%
6/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.68%
10/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
15.3%
26/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
22.0%
18/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.8%
100/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Peripheral swelling
|
5.3%
9/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.5%
22/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
3.5%
6/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.6%
23/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Congestive hepatopathy
|
0.59%
1/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.41%
6/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
5.3%
9/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.3%
6/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.6%
38/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
9.4%
16/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
9.8%
8/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.5%
51/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
9/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.3%
6/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.0%
30/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
5.9%
10/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
14.6%
12/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.6%
38/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
12/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
2/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.6%
53/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
10.6%
18/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
19.5%
16/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
5.1%
75/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.6%
13/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.7%
40/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
24.1%
41/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
41.5%
34/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
9.9%
146/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.1%
7/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.6%
24/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.5%
11/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.3%
6/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.7%
25/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
7.1%
12/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
15.9%
13/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.1%
46/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound
|
2.4%
4/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.88%
13/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.95%
14/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.3%
6/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.88%
13/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
5.9%
10/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
9.8%
8/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.2%
32/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
9/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
9.8%
8/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.4%
50/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
9/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.9%
4/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.4%
21/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Fluid retention
|
5.3%
9/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
3/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.3%
19/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Gout
|
10.6%
18/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
12.2%
10/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.7%
113/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.3%
6/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.68%
10/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.9%
5/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
35/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.3%
9/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.2%
32/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
5.9%
10/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
13.4%
11/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
5.1%
76/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.5%
23/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
20.7%
17/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.1%
61/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.5%
11/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
15.9%
13/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
35/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.1%
29/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
14.6%
12/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
5.3%
78/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.6%
18/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
14.6%
12/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.4%
65/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.2%
14/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.9%
4/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.6%
53/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.5%
11/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
8.5%
7/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.3%
19/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.1%
12/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
11.0%
9/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.4%
20/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.1%
24/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
11.0%
9/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
55/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Balance disorder
|
6.5%
11/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.9%
4/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.1%
16/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
14.1%
24/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
13.4%
11/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.6%
97/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
4.1%
7/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.3%
6/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.9%
28/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Depression
|
4.7%
8/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
9.8%
8/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.6%
23/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
7.6%
13/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
15.9%
13/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.9%
57/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
8.8%
15/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
18.3%
15/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
54/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Chronic kidney disease
|
5.9%
10/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
15.9%
13/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.4%
20/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
4.1%
7/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
13.4%
11/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.2%
47/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal failure
|
6.5%
11/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
3/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.68%
10/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.4%
21/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.1%
29/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
22.0%
18/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
5.5%
81/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
31/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
22.0%
18/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
7.5%
110/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.6%
13/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.6%
38/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
3.5%
6/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.75%
11/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.5%
23/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
29.3%
24/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.9%
58/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.2%
2/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
6.1%
5/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.54%
8/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.8%
3/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
8.5%
7/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
0.61%
9/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
17/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
9.8%
8/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
2.4%
36/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.9%
10/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
3.7%
3/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
1.7%
25/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
8.2%
14/170 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
24.4%
20/82 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
4.7%
70/1476 • B3461045: From first dose of treatment up to 28 days post last dose of study treatment (approximately up to 61 months)
Same event may appear as non-SAE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study. Safety analysis population consisted of all participants (Cohorts A and B) who were enrolled in this study and taken at least 1 dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER