Trial Outcomes & Findings for A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes (NCT NCT05168202)
NCT ID: NCT05168202
Last Updated: 2025-09-25
Results Overview
A dose-limiting toxicity (DLT) is any treatment-related toxicity during Cycle 1 (Days 1-28, up to 42) not clearly due to illness or external causes. DLTs include: * Any Grade ≥3 non-hematologic toxicity, except specific reversible or manageable cases (e.g., IRR, nausea, diarrhea, fatigue, infection with leukemia, TLS, electrolyte imbalance, liver enzyme elevations, or rash). * Any confirmed Hy's law case (ALT/AST ≥3× ULN + bilirubin \>2× ULN without cholestasis). * Hematologic toxicities: Grade 4 neutropenia/thrombocytopenia persisting at Day 28 without active AML/MDS; febrile neutropenia or Grade ≥3 thrombocytopenia with severe bleeding and prolonged myelosuppression (\>42 days) without active leukemia. * Any adverse event requiring dose reduction in Cycle 1 unless clearly unrelated to the drug.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
From Cycle 1 Day 1 to Cycle 1 Day 28 up to 42 post first dose of cycle 1 (upto 42 days)
Results posted on
2025-09-25
Participant Flow
Due to a strategic re-evaluation and prioritization of the company's portfolio, this study was terminated early during dose escalation (Part A). No participants were enrolled in Parts B, C, and D because the study was terminated prior to the start of dose expansion.
Participant milestones
| Measure |
Part A: Treatment 1
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
9
|
10
|
8
|
10
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
9
|
10
|
8
|
10
|
5
|
Reasons for withdrawal
| Measure |
Part A: Treatment 1
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
4
|
4
|
2
|
3
|
2
|
3
|
2
|
|
Overall Study
Adverse Event
|
2
|
1
|
4
|
4
|
3
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
1
|
0
|
1
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
1
|
1
|
0
|
|
Overall Study
Disease Relapse
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Other Reasons
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Part A: Treatment 1
n=6 Participants
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=8 Participants
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 Participants
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 Participants
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 Participants
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 Participants
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 Participants
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
67.0 Years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
69.4 Years
STANDARD_DEVIATION 10.82 • n=7 Participants
|
68.3 Years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
70.6 Years
STANDARD_DEVIATION 4.25 • n=4 Participants
|
67.5 Years
STANDARD_DEVIATION 14.09 • n=21 Participants
|
56.6 Years
STANDARD_DEVIATION 16.53 • n=10 Participants
|
65.4 Years
STANDARD_DEVIATION 13.37 • n=115 Participants
|
66.3 Years
STANDARD_DEVIATION 12.31 • n=24 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
26 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
30 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
31 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
18 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
37 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
16 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From Cycle 1 Day 1 to Cycle 1 Day 28 up to 42 post first dose of cycle 1 (upto 42 days)Population: Safety Population
A dose-limiting toxicity (DLT) is any treatment-related toxicity during Cycle 1 (Days 1-28, up to 42) not clearly due to illness or external causes. DLTs include: * Any Grade ≥3 non-hematologic toxicity, except specific reversible or manageable cases (e.g., IRR, nausea, diarrhea, fatigue, infection with leukemia, TLS, electrolyte imbalance, liver enzyme elevations, or rash). * Any confirmed Hy's law case (ALT/AST ≥3× ULN + bilirubin \>2× ULN without cholestasis). * Hematologic toxicities: Grade 4 neutropenia/thrombocytopenia persisting at Day 28 without active AML/MDS; febrile neutropenia or Grade ≥3 thrombocytopenia with severe bleeding and prolonged myelosuppression (\>42 days) without active leukemia. * Any adverse event requiring dose reduction in Cycle 1 unless clearly unrelated to the drug.
Outcome measures
| Measure |
Part A: Treatment 1
n=6 Participants
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=8 Participants
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 Participants
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 Participants
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 Participants
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 Participants
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 Participants
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With DLTs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: From signing informed consent to 56 days post last dose (Approximately 30 months)Population: Safety Population
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE.
Outcome measures
| Measure |
Part A: Treatment 1
n=6 Participants
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=8 Participants
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 Participants
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 Participants
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 Participants
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 Participants
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 Participants
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
6 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: From signing informed consent to 56 days post last dose (Approximately 30 months)Population: Safety Population
Clinical laboratory values from laboratories will be graded according to CTCAE Version 5 for applicable tests programmatically. For laboratory values that fall outside of the grade criteria of CTCAE Version 5, a Grade of 0 will be assigned. In addition, normal ranges will be used to determine the categories of High, Low, and Normal for laboratory tests that have no severity grade.
Outcome measures
| Measure |
Part A: Treatment 1
n=6 Participants
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=8 Participants
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 Participants
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 Participants
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 Participants
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 Participants
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 Participants
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
hemoglobin
|
4 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
platelet count
|
5 Participants
|
8 Participants
|
9 Participants
|
10 Participants
|
8 Participants
|
10 Participants
|
5 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
leukocytes
|
5 Participants
|
5 Participants
|
6 Participants
|
9 Participants
|
7 Participants
|
9 Participants
|
4 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
lymphocytes
|
4 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
2 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
neutrophils
|
3 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
Alanine aminotransferase
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
asparatate aminotransferase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
alkaline phosphatase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
bilirubin, total
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
creatinine
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
albumin
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
calcium, total
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
hyperkalemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
hypocalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
hypokalemia
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
hyponatremia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
potassium
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With With Grade 3 or Higher Laboratory Abnormalities
sodium
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From screening to 56 days post last dose (Approximately 29 months)Population: Safety Population
A single ECG will be performed in Screening, Cycle 1 Day 1 and 15, and Day 1 of Cycles ≥ 2. Investigators will make immediate clinical decisions based on their interpretation of the ECG results and provide their overall assessment.
Outcome measures
| Measure |
Part A: Treatment 1
n=6 Participants
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=8 Participants
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 Participants
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 Participants
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 Participants
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 Participants
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 Participants
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant ECG Abnormalities Presented as Adverse Events
Sinus Tachycardia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant ECG Abnormalities Presented as Adverse Events
Tachycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant ECG Abnormalities Presented as Adverse Events
Atrial Fibrillation
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant ECG Abnormalities Presented as Adverse Events
Sinus Bradycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From screening to 56 days post last dose (Approximately 29 months)Population: Safety Population - Multiple ECOG evaluations were done throughout the study at different timepoints
ECOG Scale was used to assess performance status. Grades: 0: Fully active, able to carry on all pre-disease performance without estriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. Baseline value was defined as the last non-missing value on or before the day that first dose of study drug is administered; if multiple values are present for the same date, the average of these values will be used as the baseline.
Outcome measures
| Measure |
Part A: Treatment 1
n=27 ECOG Evaluation
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=41 ECOG Evaluation
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=29 ECOG Evaluation
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=45 ECOG Evaluation
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=45 ECOG Evaluation
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=29 ECOG Evaluation
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=15 ECOG Evaluation
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Number of ECOG Evaluations With Shift of ECOG Score of 3 or Greater.
|
3 ECOG Evaluations
|
1 ECOG Evaluations
|
0 ECOG Evaluations
|
1 ECOG Evaluations
|
0 ECOG Evaluations
|
1 ECOG Evaluations
|
1 ECOG Evaluations
|
PRIMARY outcome
Timeframe: From signing informed consent to 56 days post last dose (Approximately 30 months)Population: Safety Population
Vital sign measurements include: Weight (kg), Temperature (°C), Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Pulse (beats/min), Respiration Rate (breaths/min).
Outcome measures
| Measure |
Part A: Treatment 1
n=6 Participants
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=8 Participants
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 Participants
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 Participants
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 Participants
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 Participants
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 Participants
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs Presented as AEs
Pyrexia
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs Presented as AEs
hypothermia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs Presented as AEs
hypertension
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs Presented as AEs
hypotension
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Signs Presented as AEs
weight decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1, C1D22 and C2D22.Population: Pharmacokinetic Population
Maximum plasma concentration of drug
Outcome measures
| Measure |
Part A: Treatment 1
n=6 Participants
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=7 Participants
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 Participants
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 Participants
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 Participants
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 Participants
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 Participants
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Cmax
Cycle 1 Day 1
|
371.59 ug/mL
Geometric Coefficient of Variation 25.14
|
510.58 ug/mL
Geometric Coefficient of Variation 33.39
|
209.40 ug/mL
Geometric Coefficient of Variation 14.13
|
428.72 ug/mL
Geometric Coefficient of Variation 22.78
|
636.93 ug/mL
Geometric Coefficient of Variation 7.80
|
418.39 ug/mL
Geometric Coefficient of Variation 42.61
|
653.88 ug/mL
Geometric Coefficient of Variation 10.36
|
|
Cmax
Cycle 1 Day 22
|
514.05 ug/mL
Geometric Coefficient of Variation 25.01
|
773.08 ug/mL
Geometric Coefficient of Variation 30.58
|
314.49 ug/mL
Geometric Coefficient of Variation 16.76
|
641.78 ug/mL
Geometric Coefficient of Variation 21.60
|
1055.99 ug/mL
Geometric Coefficient of Variation 18.62
|
592.41 ug/mL
Geometric Coefficient of Variation 50.25
|
1036.14 ug/mL
Geometric Coefficient of Variation 28.08
|
|
Cmax
Cycle 2 Day 22
|
568.25 ug/mL
Geometric Coefficient of Variation 32.29
|
1217.78 ug/mL
Geometric Coefficient of Variation 19.11
|
318.09 ug/mL
Geometric Coefficient of Variation 21.12
|
637.76 ug/mL
Geometric Coefficient of Variation 21.01
|
1468.00 ug/mL
Geometric Coefficient of Variation 18.85
|
833.06 ug/mL
Geometric Coefficient of Variation 38.61
|
1470.00 ug/mL
Geometric Coefficient of Variation NA
GCV not calculable due to only 1 participant analyzed
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1, C1D22 and C2D22.Population: Pharmacokinetic Population
Time to maximum plasma concentration (Tmax)
Outcome measures
| Measure |
Part A: Treatment 1
n=6 Participants
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=7 Participants
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 Participants
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 Participants
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 Participants
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 Participants
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 Participants
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Tmax
Cycle 2 Day 22
|
3.78 hours
Interval 2.2 to 4.0
|
5.02 hours
Interval 2.3 to 7.1
|
3.51 hours
Interval 1.5 to 5.3
|
12.27 hours
Interval 1.9 to 69.6
|
3.28 hours
Interval 2.8 to 5.7
|
2.14 hours
Interval 1.8 to 3.8
|
3.37 hours
Interval 3.37 to 3.37
|
|
Tmax
Cycle 1 Day 1
|
2.33 hours
Interval 1.6 to 3.9
|
4.87 hours
Interval 2.1 to 7.2
|
1.80 hours
Interval 1.6 to 5.6
|
4.02 hours
Interval 2.5 to 6.0
|
5.47 hours
Interval 3.2 to 8.3
|
4.61 hours
Interval 2.1 to 22.3
|
4.78 hours
Interval 3.5 to 5.8
|
|
Tmax
Cycle 1 Day 22
|
1.93 hours
Interval 1.5 to 2.1
|
6.80 hours
Interval 2.1 to 7.6
|
3.17 hours
Interval 1.2 to 3.6
|
3.87 hours
Interval 2.0 to 22.6
|
5.88 hours
Interval 2.5 to 23.8
|
3.42 hours
Interval 1.6 to 23.9
|
6.75 hours
Interval 3.0 to 26.1
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1, C1D22 and C2D22.Population: Pharmacokinetic Population
Area under the plasma concentration time-curve up to the last measurable concentration (AUC0-t)
Outcome measures
| Measure |
Part A: Treatment 1
n=6 Participants
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=7 Participants
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 Participants
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 Participants
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 Participants
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 Participants
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 Participants
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
AUC(0-T)
Cycle 1 Day 1
|
27915.38 h*ug/mL
Geometric Coefficient of Variation 25.74
|
37242.17 h*ug/mL
Geometric Coefficient of Variation 41.18
|
13125.85 h*ug/mL
Geometric Coefficient of Variation 48.00
|
23850.09 h*ug/mL
Geometric Coefficient of Variation 50.97
|
49377.47 h*ug/mL
Geometric Coefficient of Variation 10.90
|
28557.98 h*ug/mL
Geometric Coefficient of Variation 61.21
|
42273.81 h*ug/mL
Geometric Coefficient of Variation 28.09
|
|
AUC(0-T)
Cycle 1 Day 22
|
25766.21 h*ug/mL
Geometric Coefficient of Variation 366.57
|
53952.86 h*ug/mL
Geometric Coefficient of Variation 105.79
|
38363.45 h*ug/mL
Geometric Coefficient of Variation 34.52
|
46250.05 h*ug/mL
Geometric Coefficient of Variation 55.29
|
84673.85 h*ug/mL
Geometric Coefficient of Variation 80.82
|
63857.81 h*ug/mL
Geometric Coefficient of Variation 83.67
|
186843.83 h*ug/mL
Geometric Coefficient of Variation 120.44
|
|
AUC(0-T)
Cycle 2 Day 22
|
42891.42 h*ug/mL
Geometric Coefficient of Variation 38.09
|
54797.36 h*ug/mL
Geometric Coefficient of Variation 205.65
|
37672.97 h*ug/mL
Geometric Coefficient of Variation 30.69
|
54425.19 h*ug/mL
Geometric Coefficient of Variation 131.05
|
116229.58 h*ug/mL
Geometric Coefficient of Variation 23.27
|
74865.57 h*ug/mL
Geometric Coefficient of Variation 104.46
|
137581.5 h*ug/mL
Geometric Coefficient of Variation NA
GCV not calculable due to only 1 participant analyzed
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1, C1D22 and C2D22.Population: Pharmacokinetic Population
Area under the plasma concentration time-curve during a dosing interval (AUCtau)
Outcome measures
| Measure |
Part A: Treatment 1
n=6 Participants
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=7 Participants
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 Participants
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 Participants
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 Participants
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 Participants
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 Participants
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
AUC(TAU)
Cycle 1 Day 1
|
27915.38 h*ug/mL
Geometric Coefficient of Variation 25.74
|
39145.67 h*ug/mL
Geometric Coefficient of Variation 33.39
|
15987.61 h*ug/mL
Geometric Coefficient of Variation 16.16
|
28817.51 h*ug/mL
Geometric Coefficient of Variation 27.62
|
49377.47 h*ug/mL
Geometric Coefficient of Variation 10.90
|
29931.17 h*ug/mL
Geometric Coefficient of Variation 64.80
|
46778.93 h*ug/mL
Geometric Coefficient of Variation 18.30
|
|
AUC(TAU)
Cycle 1 Day 22
|
48306.42 h*ug/mL
Geometric Coefficient of Variation 48.94
|
87419.67 h*ug/mL
Geometric Coefficient of Variation 68.23
|
34295.76 h*ug/mL
Geometric Coefficient of Variation 16.51
|
64776.31 h*ug/mL
Geometric Coefficient of Variation 16.33
|
120818.65 h*ug/mL
Geometric Coefficient of Variation 32.18
|
57119.56 h*ug/mL
Geometric Coefficient of Variation 67.28
|
109428.93 h*ug/mL
Geometric Coefficient of Variation 41.91
|
|
AUC(TAU)
Cycle 2 Day 22
|
48436.92 h*ug/mL
Geometric Coefficient of Variation 44.72
|
128864.45 h*ug/mL
Geometric Coefficient of Variation 8.24
|
37672.97 h*ug/mL
Geometric Coefficient of Variation 30.69
|
89459.57 h*ug/mL
Geometric Coefficient of Variation 19.99
|
119737.08 h*ug/mL
Geometric Coefficient of Variation 25.79
|
114221.87 h*ug/mL
Geometric Coefficient of Variation 19.11
|
137581.85 h*ug/mL
Geometric Coefficient of Variation NA
GCV not calculable due to only 1 participant analyzed
|
SECONDARY outcome
Timeframe: On Cycle 1 Day 1, C1D22 and C2D22.Population: Pharmacokinetic Population
Minimum serum concentration
Outcome measures
| Measure |
Part A: Treatment 1
n=6 Participants
Monotherapy: CC-95251 20mg/kg
|
Part A: Treatment 2
n=7 Participants
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 Participants
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 Participants
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 Participants
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 Participants
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 Participants
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Cmin
Cycle 1 Day 1
|
NA ug/mL
Geometric Coefficient of Variation NA
Below the limit of quantification
|
1.96 ug/mL
Geometric Coefficient of Variation NA
Below the limit of quantification
|
NA ug/mL
Geometric Coefficient of Variation NA
Below the limit of quantification
|
140.00 ug/mL
Geometric Coefficient of Variation NA
Below the limit of quantification
|
NA ug/mL
Geometric Coefficient of Variation NA
Below the limit of quantification
|
NA ug/mL
Geometric Coefficient of Variation NA
Below the limit of quantification
|
0.47 ug/mL
Geometric Coefficient of Variation NA
Below the limit of quantification
|
|
Cmin
Cycle 1 Day 22
|
149.97 ug/mL
Geometric Coefficient of Variation 50.58
|
213.59 ug/mL
Geometric Coefficient of Variation 104.90
|
109.90 ug/mL
Geometric Coefficient of Variation 40.52
|
153.17 ug/mL
Geometric Coefficient of Variation 97.33
|
342.42 ug/mL
Geometric Coefficient of Variation 39.35
|
167.12 ug/mL
Geometric Coefficient of Variation 89.50
|
336.79 ug/mL
Geometric Coefficient of Variation 54.07
|
|
Cmin
Cycle 2 Day 22
|
171.28 ug/mL
Geometric Coefficient of Variation 48.96
|
588.04 ug/mL
Geometric Coefficient of Variation 36.19
|
135.10 ug/mL
Geometric Coefficient of Variation 44.61
|
225.45 ug/mL
Geometric Coefficient of Variation 37.09
|
573.75 ug/mL
Geometric Coefficient of Variation 46.78
|
291.15 ug/mL
Geometric Coefficient of Variation 94.88
|
545.00 ug/mL
Geometric Coefficient of Variation NA
Below the limit of quantification
|
Adverse Events
Part A: Treatment 1
Serious events: 6 serious events
Other events: 6 other events
Deaths: 6 deaths
Part A: Treatment 2
Serious events: 7 serious events
Other events: 8 other events
Deaths: 7 deaths
Part A: Treatment 3
Serious events: 8 serious events
Other events: 7 other events
Deaths: 6 deaths
Part A: Treatment 4
Serious events: 7 serious events
Other events: 9 other events
Deaths: 9 deaths
Part A: Treatment 5
Serious events: 7 serious events
Other events: 7 other events
Deaths: 6 deaths
Part A: Treatment 6
Serious events: 10 serious events
Other events: 10 other events
Deaths: 8 deaths
Part A: Treatment 7
Serious events: 5 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Part A: Treatment 1
n=6 participants at risk
Monotherapy : CC-95251 20mg/kg
|
Part A: Treatment 2
n=8 participants at risk
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 participants at risk
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 participants at risk
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 participants at risk
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 participants at risk
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 participants at risk
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
4/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
55.6%
5/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.0%
3/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
60.0%
6/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Ileus paralytic
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Disease progression
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Generalised oedema
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Multiple organ dysfunction syndrome
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemophagocytic lymphohistiocytosis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Device related infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia sepsis
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fungal infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Liver abscess
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Localised infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neutropenic sepsis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 fungal
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pseudomonal bacteraemia
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Puncture site abscess
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Respiratory tract infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Streptococcal sepsis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vascular device infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hip fracture
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 bilirubin increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
General physical condition abnormal
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.0%
3/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Chloroma
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Leukaemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Neoplasm progression
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cerebellar haemorrhage
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Meningorrhagia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Subarachnoid haemorrhage
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bronchospasm
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Nail bed bleeding
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Part A: Treatment 1
n=6 participants at risk
Monotherapy : CC-95251 20mg/kg
|
Part A: Treatment 2
n=8 participants at risk
Monotherapy : CC-95251 30mg/kg
|
Part A: Treatment 3
n=9 participants at risk
Combination : CC-95251 10mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 4
n=10 participants at risk
Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 5
n=8 participants at risk
Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2
|
Part A: Treatment 6
n=10 participants at risk
Triplet Combination : CC-95251 20mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
Part A: Treatment 7
n=5 participants at risk
Triplet Combination : CC-95251 30mg/kg + Azacitidine 75 mg/m2 + Venetoclax
|
|---|---|---|---|---|---|---|---|
|
Eye disorders
Eye pain
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
2/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
4/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.0%
3/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.5%
3/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukocytosis
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Leukopenia
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Neutropenia
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.0%
3/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Pancytopenia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
33.3%
2/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.5%
3/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
5/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 bradycardia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Eye irritation
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.5%
3/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
3/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
4/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Gingival bleeding
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemorrhoids
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.5%
3/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
5/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Odynophagia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Oral mucosa haematoma
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rectal haemorrhage
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tongue discolouration
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Tongue ulceration
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
33.3%
2/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.0%
3/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Adverse drug reaction
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
50.0%
3/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
4/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chest pain
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Face oedema
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Generalised oedema
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypothermia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Injection site erythema
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Injection site pain
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Injection site reaction
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Medical device site thrombosis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Mucosal inflammation
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.5%
3/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.0%
3/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Cholestasis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 pain
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypertransaminasaemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bacteraemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bacterial infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bronchopulmonary aspergillosis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Candida infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Conjunctivitis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Device related infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Enterococcal bacteraemia
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Enterocolitis infectious
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Folliculitis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Fungal infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oral candidiasis
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oral infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Oropharyngeal candidiasis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Otitis media
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Proteus infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Respiratory moniliasis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Respiratory tract infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Streptococcal bacteraemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vascular access site infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vulvovaginal mycotic infection
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Humerus fracture
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Periorbital haematoma
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 haemorrhage
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Transfusion reaction
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Vascular access site haemorrhage
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.5%
3/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
5/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.5%
3/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.0%
3/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
2/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 bilirubin increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood lactate dehydrogenase increased
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
C-reactive protein increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
General physical condition abnormal
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hepatic enzyme increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
40.0%
4/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.5%
3/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Fluid imbalance
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Folate deficiency
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Hypervolaemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
50.0%
5/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
30.0%
3/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Type 2 diabetes mellitus
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Chest wall haematoma
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Joint swelling
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Rotator cuff syndrome
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 pain
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Adrenal neoplasm
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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)
Chloroma
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Somnolence
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Taste disorder
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Initial insomnia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Bronchospasm
|
16.7%
1/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
3/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haemoptysis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Intertrigo
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
1/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Petechiae
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 lesion
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Urticaria
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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
Haematoma
|
33.3%
2/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
20.0%
2/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
22.2%
2/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
25.0%
2/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.0%
1/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.1%
1/9 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
12.5%
1/8 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/10 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/5 • Adverse Events and Serious Adverse Events and All Cause Mortality: (Approximately 30 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: 1-855-907-3286
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER