MedTrace Logo

Trial Outcomes & Findings for A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy (NCT NCT05582395)

NCT ID: NCT05582395

Last Updated: 2026-08-20

Results Overview

The KCCQ-23 is a 23-item, self-administered questionnaire that measures the impact of a participant's cardiovascular disease or its treatment on 6 distinct domains using a 2-week recall period: symptoms/signs, physical limitation, quality of life (QoL), social limitations, self-efficacy, and symptom stability. The KCCQ 23 Clinical Summary Score (CSS) is derived from the Total Symptom Score (TSS) and the Physical Limitations (PL) score of the KCCQ 23. The CSS, TSS, and the PL score range from 0 to 100 with higher scores representing less severe symptoms and/or physical limitations. The CSS is a mean of the TSS and the PL score. Baseline is defined as the last non-missing assessment prior to the first dose of the study treatment if both the time of the measurement and the time of first dose are available otherwise it is the last non-missing assessment on or prior to the first dose of the study treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

580 participants

Primary outcome timeframe

From First dose to week 48

Results posted on

2026-08-20

Participant Flow

580 participants randomized and treated

Participant milestones

Participant milestones
Measure
Treatment 1
Mavacamten starting dose of mavacamten in this study will be 5 mg QD in all participants followed by individualized LVEF-guided dose adjustments.
Treatment 2
Treatment Period: Placebo matching active treatment dosage LTE: mavacamten 5 mg QD
Treatment Period
STARTED
289
291
Treatment Period
COMPLETED
258
274
Treatment Period
NOT COMPLETED
31
17
Long Term Extension Period
STARTED
289
291
Long Term Extension Period
COMPLETED
0
0
Long Term Extension Period
NOT COMPLETED
289
291

Reasons for withdrawal

Reasons for withdrawal
Measure
Treatment 1
Mavacamten starting dose of mavacamten in this study will be 5 mg QD in all participants followed by individualized LVEF-guided dose adjustments.
Treatment 2
Treatment Period: Placebo matching active treatment dosage LTE: mavacamten 5 mg QD
Treatment Period
Lost to Follow-up
0
1
Treatment Period
Non-Compliance with study drug
0
1
Treatment Period
Physician Decision
3
0
Treatment Period
Participant request to discontinue
4
6
Treatment Period
Withdrawal by Subject
2
1
Treatment Period
Adverse Event
12
5
Treatment Period
LVEF permanent discontinuation criteria met
7
0
Treatment Period
Other Reasons
3
3
Long Term Extension Period
Lost to Follow-up
0
1
Long Term Extension Period
Non-compliance with study drug
0
1
Long Term Extension Period
Physician Decision
4
1
Long Term Extension Period
study closed out early due to sponsor
251
259
Long Term Extension Period
participant request to discontinue treatment
4
12
Long Term Extension Period
Withdrawal by Subject
3
3
Long Term Extension Period
Adverse Event
15
8
Long Term Extension Period
LVEF permanent discontinuation criteria met
7
1
Long Term Extension Period
Other Reasons
5
5

Baseline Characteristics

A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment 1
n=289 Participants
Mavacamten starting dose of mavacamten in this study will be 5 mg QD in all participants followed by individualized LVEF-guided dose adjustments.
Treatment 2
n=291 Participants
Treatment Period: Placebo matching active treatment dosage LTE: mavacamten 5 mg QD
Total
n=580 Participants
Total of all reporting groups
Age, Continuous
56.4 Years
STANDARD_DEVIATION 14.71 • n=5 Participants
55.7 Years
STANDARD_DEVIATION 14.39 • n=109 Participants
56.0 Years
STANDARD_DEVIATION 14.54 • n=133 Participants
Sex: Female, Male
Female
141 Participants
n=5 Participants
125 Participants
n=109 Participants
266 Participants
n=133 Participants
Sex: Female, Male
Male
148 Participants
n=5 Participants
166 Participants
n=109 Participants
314 Participants
n=133 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
40 Participants
n=5 Participants
42 Participants
n=109 Participants
82 Participants
n=133 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
215 Participants
n=5 Participants
222 Participants
n=109 Participants
437 Participants
n=133 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
34 Participants
n=5 Participants
27 Participants
n=109 Participants
61 Participants
n=133 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=109 Participants
0 Participants
n=133 Participants
Race (NIH/OMB)
Asian
51 Participants
n=5 Participants
39 Participants
n=109 Participants
90 Participants
n=133 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=109 Participants
0 Participants
n=133 Participants
Race (NIH/OMB)
Black or African American
11 Participants
n=5 Participants
14 Participants
n=109 Participants
25 Participants
n=133 Participants
Race (NIH/OMB)
White
195 Participants
n=5 Participants
205 Participants
n=109 Participants
400 Participants
n=133 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=109 Participants
0 Participants
n=133 Participants
Race (NIH/OMB)
Unknown or Not Reported
32 Participants
n=5 Participants
33 Participants
n=109 Participants
65 Participants
n=133 Participants

PRIMARY outcome

Timeframe: From First dose to week 48

Population: All participants with a KCCQ-23 evaluation at week 48

The KCCQ-23 is a 23-item, self-administered questionnaire that measures the impact of a participant's cardiovascular disease or its treatment on 6 distinct domains using a 2-week recall period: symptoms/signs, physical limitation, quality of life (QoL), social limitations, self-efficacy, and symptom stability. The KCCQ 23 Clinical Summary Score (CSS) is derived from the Total Symptom Score (TSS) and the Physical Limitations (PL) score of the KCCQ 23. The CSS, TSS, and the PL score range from 0 to 100 with higher scores representing less severe symptoms and/or physical limitations. The CSS is a mean of the TSS and the PL score. Baseline is defined as the last non-missing assessment prior to the first dose of the study treatment if both the time of the measurement and the time of first dose are available otherwise it is the last non-missing assessment on or prior to the first dose of the study treatment.

Outcome measures

Outcome measures
Measure
Treatment 1
n=289 Participants
Mavacamten starting dose of mavacamten in this study will be 5 mg QD in all participants followed by individualized LVEF-guided dose adjustments.
Treatment 2
n=291 Participants
Treatment Period: Placebo matching active treatment dosage LTE: mavacamten 5 mg QD
Change From Baseline in KCCQ-23 CSS at Week 48
13.13 Score on a Scale
Standard Error 1.222
10.38 Score on a Scale
Standard Error 1.214

PRIMARY outcome

Timeframe: From First dose to week 48

Population: All participants with a pVO2 evaluation at week 48

Clinically meaningful mean change from baseline(1.4ml/kg/min) of pVO2 at Week 48.

Outcome measures

Outcome measures
Measure
Treatment 1
n=289 Participants
Mavacamten starting dose of mavacamten in this study will be 5 mg QD in all participants followed by individualized LVEF-guided dose adjustments.
Treatment 2
n=291 Participants
Treatment Period: Placebo matching active treatment dosage LTE: mavacamten 5 mg QD
Change From Baseline in pVO2 at Week 48
0.52 mL/kg/min
Standard Error 0.220
0.05 mL/kg/min
Standard Error 0.216

SECONDARY outcome

Timeframe: From First dose to week 48

Population: All participants with a VE/VCO2 slope evaluation at week 48

VE/VCO₂ slope was assessed using cardiopulmonary exercise testing (CPET). The slope was calculated as the linear regression of minute ventilation (VE) against carbon dioxide production (VCO₂). A decrease in VE/VCO₂ slope reflects improved ventilatory efficiency.

Outcome measures

Outcome measures
Measure
Treatment 1
n=289 Participants
Mavacamten starting dose of mavacamten in this study will be 5 mg QD in all participants followed by individualized LVEF-guided dose adjustments.
Treatment 2
n=291 Participants
Treatment Period: Placebo matching active treatment dosage LTE: mavacamten 5 mg QD
Change From Baseline in VE/VCO2 Slope at Week 48
-0.64 ratio
Standard Error 0.608
0.16 ratio
Standard Error 0.603

SECONDARY outcome

Timeframe: From First dose to week 48

Population: All participants with at least 1 NT - proBNP evaluation at week 48

Blood samples were collected for assessing the concentration of NT-proBNP. Baseline is defined as last non-missing measurement prior to the first dose.

Outcome measures

Outcome measures
Measure
Treatment 1
n=289 Participants
Mavacamten starting dose of mavacamten in this study will be 5 mg QD in all participants followed by individualized LVEF-guided dose adjustments.
Treatment 2
n=291 Participants
Treatment Period: Placebo matching active treatment dosage LTE: mavacamten 5 mg QD
Mean Change From Baseline in NT-proBNP to Week 48
0.42 ng/L
Geometric Coefficient of Variation 5.842
1.02 ng/L
Geometric Coefficient of Variation 5.655

SECONDARY outcome

Timeframe: From First dose to week 48

Population: All participants with at least 1 NYHA evaluation at week 48

Participants with \\\>= 1 NYHA function class improvement. The NYHA Functional Classification of heart failure assigns participants to 1 of 4 categories based on the participant's symptoms. Class 1: No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class 2: Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class 3: Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class 4: Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.

Outcome measures

Outcome measures
Measure
Treatment 1
n=289 Participants
Mavacamten starting dose of mavacamten in this study will be 5 mg QD in all participants followed by individualized LVEF-guided dose adjustments.
Treatment 2
n=291 Participants
Treatment Period: Placebo matching active treatment dosage LTE: mavacamten 5 mg QD
Percentage of Participants With at Least 1 Class of NYHA Improvement From Baseline at Week 48
36.33 Percentage of Participants
Interval 30.79 to 41.88
31.62 Percentage of Participants
Interval 26.27 to 36.96

SECONDARY outcome

Timeframe: From First dose to week 48

Population: All participants with HCMSQ SoB Domain Score evaluation at week 48

The HCMSQ is a self- administered, 9-item questionnaire that assesses the core symptoms of HCM (shortness of breath, tiredness/fatigue, heart palpitations, chest pain, dizziness, and syncope). At each visit, a 7-day period will be defined, ending on the last day with a non-missing HCMSQ score prior to the actual clinic visit (or first dose date if baseline). If the participant completes the HCMSQ for 4 or more days within this period, the weekly average HCMSQ score will be calculated. If fewer than 4 days are completed, other 7-day periods will be considered. For baseline, any 7-day period with at least 4 days of HCMSQ prior to the first dose or randomization date (if first dose date is missing) will be used. Each domain of the SoB scale is scored 1 to 6. The scores are added together to give a total score. Lower scores indicating low to no shortness of breath, higher scores indicating frequent episodes of shortness of breath. the lower the score the better.

Outcome measures

Outcome measures
Measure
Treatment 1
n=289 Participants
Mavacamten starting dose of mavacamten in this study will be 5 mg QD in all participants followed by individualized LVEF-guided dose adjustments.
Treatment 2
n=291 Participants
Treatment Period: Placebo matching active treatment dosage LTE: mavacamten 5 mg QD
Mean Change From Baseline in HCMSQ SoB Domain Score at Week 48
-1.76 Score on a Scale
Standard Error 0.208
-1.06 Score on a Scale
Standard Error 0.207

Adverse Events

PLACEBO/MAVACAMTEN

Serious events: 55 serious events
Other events: 192 other events
Deaths: 2 deaths

MAVACAMTEN

Serious events: 18 serious events
Other events: 26 other events
Deaths: 1 deaths

PLACEBO

Serious events: 8 serious events
Other events: 17 other events
Deaths: 1 deaths

MAVACAMTEN/MAVACAMTEN

Serious events: 63 serious events
Other events: 201 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
PLACEBO/MAVACAMTEN
n=271 participants at risk
All treated subjects who received placebo in part A and mavacamten in part B and C
MAVACAMTEN
n=34 participants at risk
All treated subjects who received mavacamten in part A only
PLACEBO
n=19 participants at risk
All treated subjects who received placebo in part A only
MAVACAMTEN/MAVACAMTEN
n=254 participants at risk
All treated subjects who received mavacamten in part A and mavacamten in part B and C
Blood and lymphatic system disorders
Blood disorder
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Acute left ventricular failure
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Angina pectoris
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
1.2%
3/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Angina unstable
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Arrhythmia
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Atrial fibrillation
3.7%
10/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
20.6%
7/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
10.5%
2/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.8%
7/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Atrial flutter
1.5%
4/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
1.2%
3/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Atrial tachycardia
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Atrioventricular block complete
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Atrioventricular block second degree
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Cardiac arrest
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Cardiac failure
1.8%
5/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
17.6%
6/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.4%
6/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Cardiac failure acute
1.1%
3/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Cardiac failure congestive
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
8.8%
3/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Cardiogenic shock
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Conduction disorder
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Cor pulmonale acute
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Coronary artery disease
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Heart failure with preserved ejection fraction
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Heart failure with reduced ejection fraction
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Left ventricular failure
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Pacing induced cardiomyopathy
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Palpitations
1.1%
3/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Sinus node dysfunction
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Tachycardia paroxysmal
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Ventricular fibrillation
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Ventricular tachycardia
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Congenital, familial and genetic disorders
Odontogenic cyst
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Ear and labyrinth disorders
Vertigo
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Ear and labyrinth disorders
Vestibular disorder
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders
Hyperparathyroidism primary
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders
Cataract
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Abdominal hernia
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Diarrhoea
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Intra-abdominal fluid collection
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Melaena
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Nausea
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Pancreatitis
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Pancreatitis acute
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders
Oedema peripheral
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Vomiting
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders
Death
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders
Non-cardiac chest pain
1.1%
3/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders
Cholangitis
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders
Cholecystitis
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders
Cholelithiasis
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Immune system disorders
Anaphylactic reaction
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Anal abscess
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Appendicitis
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Dengue fever
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Diverticulitis
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Gastroenteritis
0.74%
2/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Influenza
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Klebsiella bacteraemia
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Listeria encephalitis
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Pneumonia
1.8%
5/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Pneumonia bacterial
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Postoperative wound infection
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Rectal abscess
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Tubo-ovarian abscess
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Upper respiratory tract infection
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations
Cytology abnormal
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Urinary tract infection
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Abdominal wound dehiscence
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Alcohol poisoning
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Compression fracture
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Concussion
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Femoral neck fracture
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Intentional overdose
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Post procedural complication
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Post procedural haematoma
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Seroma
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Spinal fracture
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Wound haemorrhage
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Wrist fracture
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations
Blood creatine phosphokinase increased
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations
Liver function test increased
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations
Venous pressure increased
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders
Dehydration
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders
Hypovolaemia
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders
Back pain
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders
Spinal stenosis
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Cerebral artery embolism
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Cerebral haemorrhage
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Cerebral infarction
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Cerebrovascular accident
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Hypoaesthesia
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Ischaemic stroke
0.74%
2/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Myoclonus
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Presyncope
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Sciatica
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Seizure
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Syncope
1.1%
3/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.0%
5/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Thrombotic stroke
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Transient global amnesia
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Transient ischaemic attack
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Product Issues
Device lead damage
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Product Issues
Device malfunction
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders
Disorientation
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders
Psychiatric decompensation
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders
Psychotic disorder
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders
Acute kidney injury
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders
Bladder disorder
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders
Haematuria
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders
Oliguria
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders
Renal haematoma
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Reproductive system and breast disorders
Endometriosis
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Asthma
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.74%
2/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.74%
2/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders
Hypertension
0.74%
2/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders
Phlebitis
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders
Raynaud's phenomenon
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders
Superficial vein thrombosis
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Other adverse events

Other adverse events
Measure
PLACEBO/MAVACAMTEN
n=271 participants at risk
All treated subjects who received placebo in part A and mavacamten in part B and C
MAVACAMTEN
n=34 participants at risk
All treated subjects who received mavacamten in part A only
PLACEBO
n=19 participants at risk
All treated subjects who received placebo in part A only
MAVACAMTEN/MAVACAMTEN
n=254 participants at risk
All treated subjects who received mavacamten in part A and mavacamten in part B and C
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Angina pectoris
7.0%
19/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
6.7%
17/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Atrial fibrillation
9.2%
25/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
14.7%
5/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
10.5%
2/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
11.8%
30/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Atrial flutter
2.2%
6/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
8.8%
3/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
1.6%
4/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Atrial tachycardia
0.74%
2/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
1.2%
3/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Cardiac disorder
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Cardiac failure
5.5%
15/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
20.6%
7/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
15/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Cardiac failure congestive
0.74%
2/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Coronary artery disease
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Palpitations
10.3%
28/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
26.3%
5/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
15.0%
38/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Cardiac disorders
Supraventricular tachycardia
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
1.2%
3/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Abdominal discomfort
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Diarrhoea
6.6%
18/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
6.7%
17/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Dyspepsia
2.6%
7/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
1.6%
4/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Nausea
4.1%
11/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
6.7%
17/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders
Vomiting
1.8%
5/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.8%
7/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders
Chest discomfort
2.6%
7/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
15/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders
Chest pain
2.6%
7/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.1%
13/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders
Exercise tolerance decreased
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders
Fatigue
12.2%
33/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
11.8%
4/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
18.1%
46/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders
Non-cardiac chest pain
3.7%
10/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
3.5%
9/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders
Oedema peripheral
6.3%
17/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
8.7%
22/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders
Hepatic cirrhosis
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Hepatobiliary disorders
Portal vein thrombosis
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Bronchitis
6.6%
18/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
7.1%
18/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
COVID-19
8.9%
24/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
9.8%
25/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Dengue fever
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
1.2%
3/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Influenza
5.9%
16/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
7.9%
20/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Nasopharyngitis
11.4%
31/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
10.5%
2/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
14.2%
36/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Pharyngitis
1.1%
3/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
1.2%
3/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Pneumonia
2.6%
7/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.0%
5/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Sinusitis
2.6%
7/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
3.9%
10/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Tooth abscess
1.1%
3/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Upper respiratory tract infection
7.4%
20/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
8.8%
3/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
6.3%
16/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Urinary tract infection
4.1%
11/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
7.1%
18/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations
Viral infection
1.8%
5/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications
Wrist fracture
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations
Blood pressure increased
0.74%
2/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders
Back pain
4.8%
13/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
7.5%
19/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.74%
2/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders
Neck pain
2.2%
6/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
1.2%
3/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders
Osteochondritis
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders
Pain in extremity
2.2%
6/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.8%
7/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Dizziness
12.5%
34/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
8.8%
3/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
15.8%
3/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
15.0%
38/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Dysaesthesia
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Headache
7.7%
21/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
10.5%
2/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
9.4%
24/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Sensory disturbance
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Syncope
3.0%
8/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
4.3%
11/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders
Transient ischaemic attack
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders
Anxiety
1.8%
5/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.8%
7/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders
Insomnia
1.1%
3/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
1.2%
3/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders
Mixed anxiety and depressive disorder
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders
Renal impairment
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.9%
2/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Cough
3.7%
10/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
2.9%
1/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.1%
13/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Dyspnoea
15.1%
41/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
26.5%
9/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
15.8%
3/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
18.1%
46/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.39%
1/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
4.1%
11/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
4.7%
12/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders
Pruritus
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders
Skin exfoliation
0.00%
0/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders
Hot flush
0.37%
1/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.79%
2/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders
Hypertension
2.6%
7/271 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
0.00%
0/34 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
5.3%
1/19 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
4.7%
12/254 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 120 days): Approximately 173 Weeks All-Cause mortality (From randomization to end of study): Approximately 178 Weeks
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email

Results disclosure agreements

  • Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
  • Publication restrictions are in place

Restriction type: OTHER