Trial Outcomes & Findings for Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia (NCT NCT04362813)
NCT ID: NCT04362813
Last Updated: 2022-01-24
Results Overview
Number of responders who survived without requiring invasive mechanical ventilation from Day 3 to Day 29. An early dropout without requiring invasive mechanical ventilation is considered as a responder if discharged from hospital with 9-point ordinal scale\<=1 or with last 9-point ordinal scale on/after Day 15 better than baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
454 participants
Primary outcome timeframe
Day 3 to Day 29
Results posted on
2022-01-24
Participant Flow
Participants took part at 39 investigative sites in 6 countries. While patient flow shows 454 participants enrolled, only 451 randomized. 3 were "mis-randomized" i.e. assigned a randomization number in error and not treated.
Participants were screened within 24 hours prior to enrollment.
Participant milestones
| Measure |
Canakinumab
Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Placebo
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
227
|
227
|
|
Overall Study
Safety Set
|
225
|
223
|
|
Overall Study
Completed Day 29
|
211
|
206
|
|
Overall Study
COMPLETED
|
209
|
202
|
|
Overall Study
NOT COMPLETED
|
18
|
25
|
Reasons for withdrawal
| Measure |
Canakinumab
Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Placebo
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
|---|---|---|
|
Overall Study
Death
|
12
|
16
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Enrolled but did not receive treatment
|
2
|
4
|
Baseline Characteristics
Study of Efficacy and Safety of Canakinumab Treatment for CRS in Participants With COVID-19-induced Pneumonia
Baseline characteristics by cohort
| Measure |
Canakinumab
n=227 Participants
Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Placebo
n=227 Participants
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Total
n=454 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 14.55 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 13.89 • n=7 Participants
|
58.2 years
STANDARD_DEVIATION 14.21 • n=5 Participants
|
|
Age, Customized
< 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 64 years
|
149 Participants
n=5 Participants
|
155 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
78 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
159 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 3 to Day 29Population: Randomized participants with at least one assessment of the 9-point ordinal scale between Day 3 and Day 29 (where value 0 = uninfected, and 8 = death)
Number of responders who survived without requiring invasive mechanical ventilation from Day 3 to Day 29. An early dropout without requiring invasive mechanical ventilation is considered as a responder if discharged from hospital with 9-point ordinal scale\<=1 or with last 9-point ordinal scale on/after Day 15 better than baseline.
Outcome measures
| Measure |
Canakinumab
n=223 Participants
Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Placebo
n=223 Participants
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
|---|---|---|
|
Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis
|
198 Participants
|
191 Participants
|
SECONDARY outcome
Timeframe: 29 daysPopulation: All randomized participants including those who did not receive any dose, as per intent-to-treat principle, and excluding early dropouts if the last available 9-point ordinal scale \>1 (including non-COVID-19 related death)
Participants with COVID-19 related (as assessed by investigator) death up to Day 29
Outcome measures
| Measure |
Canakinumab
n=223 Participants
Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Placebo
n=222 Participants
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
|---|---|---|
|
COVID-19-related Death After Study Treatment
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Over time and up to day 29: Baseline, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 27 and Day 29.Population: Randomized participants with a valid assessment for the outcome measure.
Measurement of C Reactive Protein (mg/L), Serum Or Plasma over time. The level of C-reactive protein (CRP), which can be measured in the blood, increases when there's inflammation in the body. Lower values of ratio to baseline in the CRP indicates less inflammation. The ratio to baseline at each time point (day) for each patient is calculated as the level of a specific biomarker at the time point divided by the baseline level of the biomarker, where baseline is the last non-missing value before study treatment. The geometric mean of ratio to baseline at each time point for each treatment group is calculated by first averaging the logarithms of the ratios to baseline and then take the exponential function of the same base.
Outcome measures
| Measure |
Canakinumab
n=227 Participants
Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Placebo
n=227 Participants
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
|---|---|---|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 13
|
0.108 ratio
Interval 0.072 to 0.162
|
0.141 ratio
Interval 0.087 to 0.228
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 15
|
0.133 ratio
Interval 0.086 to 0.205
|
0.149 ratio
Interval 0.088 to 0.252
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 17
|
0.123 ratio
Interval 0.069 to 0.22
|
0.289 ratio
Interval 0.189 to 0.441
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 19
|
0.123 ratio
Interval 0.059 to 0.255
|
0.368 ratio
Interval 0.227 to 0.598
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 21
|
0.115 ratio
Interval 0.053 to 0.247
|
0.296 ratio
Interval 0.164 to 0.533
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 23
|
0.106 ratio
Interval 0.036 to 0.311
|
0.400 ratio
Interval 0.201 to 0.796
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 25
|
0.126 ratio
Interval 0.024 to 0.633
|
0.368 ratio
Interval 0.16 to 0.846
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 27
|
0.175 ratio
Interval 0.041 to 0.743
|
0.331 ratio
Interval 0.152 to 0.72
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 29
|
0.240 ratio
Interval 0.052 to 1.106
|
0.258 ratio
Interval 0.121 to 0.551
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 2
|
0.726 ratio
Interval 0.671 to 0.786
|
0.785 ratio
Interval 0.722 to 0.853
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 3
|
0.479 ratio
Interval 0.43 to 0.534
|
0.649 ratio
Interval 0.578 to 0.729
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 5
|
0.255 ratio
Interval 0.222 to 0.292
|
0.384 ratio
Interval 0.325 to 0.454
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 7
|
0.160 ratio
Interval 0.129 to 0.198
|
0.238 ratio
Interval 0.195 to 0.29
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 9
|
0.131 ratio
Interval 0.101 to 0.171
|
0.159 ratio
Interval 0.126 to 0.201
|
|
Geometric Mean Ratio to Baseline in the C-reactive Protein (CRP)
Day 11
|
0.099 ratio
Interval 0.073 to 0.133
|
0.133 ratio
Interval 0.096 to 0.185
|
SECONDARY outcome
Timeframe: Over time and up to day 29: Baseline, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 27 and Day 29.Population: FAS
Clinical chemistry measurement D-Dimer (mg/L FEU), Blood in a blood sample over time D-dimer is one of the protein fragments produced when a blood clot gets dissolved in the body. The ratio to baseline at each time point (day) for each patient is calculated as the level of a specific biomarker at the time point divided by the baseline level of the biomarker, where baseline is the last non-missing value before study treatment. The geometric mean of ratio to baseline at each time point for each treatment group is calculated by first averaging the logarithms of the ratios to baseline and then take the exponential function of the same base.
Outcome measures
| Measure |
Canakinumab
n=227 Participants
Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Placebo
n=227 Participants
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
|---|---|---|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 2
|
1.032 ratio
Interval 0.91 to 1.17
|
1.028 ratio
Interval 0.948 to 1.114
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 3
|
0.992 ratio
Interval 0.866 to 1.135
|
1.188 ratio
Interval 1.004 to 1.242
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 5
|
1.094 ratio
Interval 0.971 to 1.233
|
1.188 ratio
Interval 1.061 to 1.33
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 7
|
1.038 ratio
Interval 0.851 to 1.267
|
1.244 ratio
Interval 1.088 to 1.422
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 9
|
1.164 ratio
Interval 0.961 to 1.41
|
1.184 ratio
Interval 1.003 to 1.422
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 11
|
1.162 ratio
Interval 0.929 to 1.453
|
1.115 ratio
Interval 0.896 to 1.388
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 13
|
1.135 ratio
Interval 0.891 to 1.447
|
1.184 ratio
Interval 0.927 to 1.513
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 15
|
1.100 ratio
Interval 0.8 to 1.514
|
1.078 ratio
Interval 0.862 to 1.349
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 17
|
1.033 ratio
Interval 0.698 to 1.528
|
1.384 ratio
Interval 1.041 to 1.838
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 19
|
1.520 ratio
Interval 0.853 to 2.711
|
1.446 ratio
Interval 1.005 to 2.081
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 21
|
1.431 ratio
Interval 0.77 to 2.659
|
1.443 ratio
Interval 0.958 to 2.172
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 23
|
1.208 ratio
Interval 0.495 to 2.95
|
1.521 ratio
Interval 1.093 to 2.118
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 25
|
2.670 ratio
Interval 0.362 to 3.891
|
1.808 ratio
Interval 0.969 to 3.371
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 27
|
1.785 ratio
Interval 0.644 to 4.949
|
2.262 ratio
Interval 1.008 to 5.075
|
|
Geometric Mean Ratio to Baseline in the D-dimer
Day 29
|
1.818 ratio
Interval 0.627 to 5.27
|
2.441 ratio
Interval 0.912 to 6.534
|
SECONDARY outcome
Timeframe: Over time and up to day 29: Baseline, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15, Day 17, Day 19, Day 21, Day 23, Day 25, Day 27 and Day 29.Population: Randomized participants with a valid assessment for the outcome measure.
Clinical chemistry measurement for amount of ferritin (ug/L) in Serum. The ratio to baseline at each time point (day) for each patient is calculated as the level of a specific biomarker at the time point divided by the baseline level of the biomarker, where baseline is the last non-missing value before study treatment. The geometric mean of ratio to baseline at each time point for each treatment group is calculated by first averaging the logarithms of the ratios to baseline and then take the exponential function of the same base.
Outcome measures
| Measure |
Canakinumab
n=227 Participants
Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Placebo
n=227 Participants
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
|---|---|---|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 2
|
0.996 ratio
Interval 0.953 to 1.04
|
1.014 ratio
Interval 0.972 to 1.058
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 3
|
0.921 ratio
Interval 0.87 to 0.976
|
1.014 ratio
Interval 0.954 to 1.077
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 5
|
0.825 ratio
Interval 0.765 to 0.889
|
0.879 ratio
Interval 0.81 to 0.953
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 7
|
0.761 ratio
Interval 0.701 to 0.826
|
0.815 ratio
Interval 0.742 to 0.896
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 9
|
0.676 ratio
Interval 0.609 to 0.751
|
0.764 ratio
Interval 0.679 to 0.859
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 11
|
0.618 ratio
Interval 0.548 to 0.698
|
0.735 ratio
Interval 0.637 to 0.849
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 13
|
0.582 ratio
Interval 0.501 to 0.675
|
0.684 ratio
Interval 0.563 to 0.83
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 15
|
0.535 ratio
Interval 0.448 to 0.638
|
0.618 ratio
Interval 0.51 to 0.75
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 17
|
0.534 ratio
Interval 0.449 to 0.634
|
0.641 ratio
Interval 0.495 to 0.832
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 19
|
0.545 ratio
Interval 0.42 to 0.707
|
0.644 ratio
Interval 0.464 to 0.893
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 21
|
0.514 ratio
Interval 0.377 to 0.7
|
0.644 ratio
Interval 0.439 to 0.944
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 23
|
0.469 ratio
Interval 0.294 to 0.749
|
0.692 ratio
Interval 0.432 to 1.109
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 25
|
0.542 ratio
Interval 0.31 to 0.945
|
0.745 ratio
Interval 0.524 to 1.059
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 27
|
0.490 ratio
Interval 0.299 to 0.802
|
0.809 ratio
Interval 0.48 to 1.363
|
|
Geometric Mean Ratio to Baseline in Ferritin
Day 29
|
0.543 ratio
Interval 0.212 to 1.393
|
0.517 ratio
Interval 0.298 to 0.896
|
SECONDARY outcome
Timeframe: Up to day 127Population: Safety Set comprises all participants who received at least one dose of study treatment
Number of participants with treatment emergent adverse events, including changes from baseline in vital signs and laboratory results qualifying and reported as adverse events. Safety was monitored from the canakinumab or placebo dose (Day 1) up to 126 days post-dose (Day 127).
Outcome measures
| Measure |
Canakinumab
n=225 Participants
Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Placebo
n=223 Participants
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
141 Participants
|
140 Participants
|
Adverse Events
Canakinumab
Serious events: 47 serious events
Other events: 15 other events
Deaths: 22 deaths
Placebo
Serious events: 53 serious events
Other events: 19 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Canakinumab
n=225 participants at risk
Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Placebo
n=223 participants at risk
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.90%
2/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.90%
2/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.89%
2/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.89%
2/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.90%
2/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.89%
2/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
General disorders
Asthenia
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
General disorders
Sudden death
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Abscess limb
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Antibiotic associated colitis
|
0.89%
2/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Bacterial sepsis
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
COVID-19
|
0.89%
2/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.3%
3/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.3%
3/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Candida infection
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Enterocolitis viral
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Escherichia sepsis
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Pneumonia
|
0.89%
2/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.3%
3/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.90%
2/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Pneumonia fungal
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.90%
2/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Sepsis
|
1.3%
3/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.90%
2/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Septic shock
|
1.3%
3/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.2%
5/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.90%
2/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Nervous system disorders
Seizure
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Psychiatric disorders
Bipolar disorder
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
3/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
3.1%
7/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute lung injury
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
2.7%
6/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.3%
3/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
5.3%
12/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
5.8%
13/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.3%
3/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.89%
2/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.8%
4/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.89%
2/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.3%
3/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.90%
2/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.90%
2/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.6%
8/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
3.6%
8/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Vascular disorders
Hypotension
|
0.89%
2/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.3%
3/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.45%
1/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Vascular disorders
Shock
|
0.44%
1/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
Other adverse events
| Measure |
Canakinumab
n=225 participants at risk
Canakinumab 450 mg for body weight 40-\<60 kg, 600 mg for 60-80 kg or 750 mg for \>80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
Placebo
n=223 participants at risk
250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
6/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
5.4%
12/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Vascular disorders
Hypotension
|
5.3%
12/225 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
4.5%
10/223 • Adverse events were collected from first dose of study treatment until end of study at day 127
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment. Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Publications from a single-site are postponed until publication of the pooled clinical trial data (i.e., data from all sites) or disclosure of trial results in their entirety
- Publication restrictions are in place
Restriction type: OTHER