Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19 (NCT NCT04315298)
NCT ID: NCT04315298
Last Updated: 2021-09-23
Results Overview
Percent Change from Baseline in C-Reactive Protein (CRP) Levels at Day 4 in Participants with Serum Interleukin 6 (IL-6) Level Greater than the Upper Limit of Normal (ULN) Least Squares (LS) means estimate of percent change from baseline at Day 4 (raw scale) for each treatment group is based on the Analysis of Covariance (ANCOVA) model. It is defined as anti-log of the estimate of dependent variable minus 1, i.e., (exp\[ln(CRP at day 4/Baseline CRP)\]-1. Negative numbers imply improvement in CRP.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1912 participants
Primary outcome timeframe
Baseline and Day 4
Results posted on
2021-09-23
Participant Flow
Of 1946 participants screened, 1912 were randomized and 1861 were treated. 51 randomized participants were never treated: 26 withdrew consent, 14 investigator decision, 9 deaths, and 3 other.
Participant milestones
| Measure |
Phase 2: Placebo
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 2: Sarilumab 200mg IV
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 2: Sarilumab 400mg IV
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Placebo - Critical
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
90
|
187
|
180
|
170
|
242
|
338
|
70
|
140
|
137
|
46
|
95
|
92
|
8
|
12
|
15
|
15
|
16
|
6
|
2
|
|
Overall Study
COMPLETED
|
61
|
117
|
125
|
101
|
157
|
209
|
52
|
111
|
101
|
29
|
53
|
51
|
5
|
8
|
9
|
9
|
13
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
29
|
70
|
55
|
69
|
85
|
129
|
18
|
29
|
36
|
17
|
42
|
41
|
3
|
4
|
6
|
6
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase 2: Placebo
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 2: Sarilumab 200mg IV
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 2: Sarilumab 400mg IV
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Placebo - Critical
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
2
|
2
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
10
|
6
|
8
|
12
|
13
|
9
|
16
|
14
|
0
|
2
|
1
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Death
|
24
|
60
|
49
|
59
|
70
|
114
|
9
|
12
|
21
|
16
|
40
|
40
|
3
|
4
|
6
|
4
|
3
|
1
|
0
|
Baseline Characteristics
ITT population
Baseline characteristics by cohort
| Measure |
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 2: Sarilumab 200mg IV
n=187 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 2: Sarilumab 400mg IV
n=180 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Placebo - Critical
n=170 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1 :Sarilumab 400mg IV - Severe
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=8 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=12 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=15 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Total
n=1861 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
21 Participants
n=90 Participants
|
63 Participants
n=187 Participants
|
42 Participants
n=180 Participants
|
59 Participants
n=170 Participants
|
67 Participants
n=242 Participants
|
111 Participants
n=338 Participants
|
25 Participants
n=70 Participants
|
59 Participants
n=140 Participants
|
51 Participants
n=137 Participants
|
21 Participants
n=46 Participants
|
41 Participants
n=95 Participants
|
34 Participants
n=92 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=12 Participants
|
4 Participants
n=15 Participants
|
4 Participants
n=15 Participants
|
5 Participants
n=16 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
617 Participants
n=1861 Participants
|
|
Age, Continuous
|
60.3 Years
STANDARD_DEVIATION 13.4 • n=90 Participants
|
57.1 Years
STANDARD_DEVIATION 14.6 • n=187 Participants
|
56.3 Years
STANDARD_DEVIATION 14.7 • n=180 Participants
|
60.1 Years
STANDARD_DEVIATION 15.0 • n=170 Participants
|
58.5 Years
STANDARD_DEVIATION 13.7 • n=242 Participants
|
61.8 Years
STANDARD_DEVIATION 14.2 • n=338 Participants
|
61.2 Years
STANDARD_DEVIATION 13.9 • n=70 Participants
|
61.3 Years
STANDARD_DEVIATION 15.1 • n=140 Participants
|
62.2 Years
STANDARD_DEVIATION 15.3 • n=137 Participants
|
59.9 Years
STANDARD_DEVIATION 13.7 • n=46 Participants
|
59.1 Years
STANDARD_DEVIATION 12.4 • n=95 Participants
|
61.1 Years
STANDARD_DEVIATION 15.1 • n=92 Participants
|
58.3 Years
STANDARD_DEVIATION 11.9 • n=8 Participants
|
57.7 Years
STANDARD_DEVIATION 7.0 • n=12 Participants
|
65.2 Years
STANDARD_DEVIATION 8.0 • n=15 Participants
|
48.6 Years
STANDARD_DEVIATION 15.3 • n=15 Participants
|
52.9 Years
STANDARD_DEVIATION 14.7 • n=16 Participants
|
61.5 Years
STANDARD_DEVIATION 9.1 • n=6 Participants
|
66.0 Years
STANDARD_DEVIATION 7.1 • n=2 Participants
|
59.7 Years
STANDARD_DEVIATION 14.4 • n=1861 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=90 Participants
|
124 Participants
n=187 Participants
|
138 Participants
n=180 Participants
|
111 Participants
n=170 Participants
|
175 Participants
n=242 Participants
|
227 Participants
n=338 Participants
|
45 Participants
n=70 Participants
|
81 Participants
n=140 Participants
|
86 Participants
n=137 Participants
|
25 Participants
n=46 Participants
|
54 Participants
n=95 Participants
|
58 Participants
n=92 Participants
|
4 Participants
n=8 Participants
|
9 Participants
n=12 Participants
|
11 Participants
n=15 Participants
|
11 Participants
n=15 Participants
|
11 Participants
n=16 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=2 Participants
|
1244 Participants
n=1861 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=90 Participants
|
54 Participants
n=187 Participants
|
40 Participants
n=180 Participants
|
59 Participants
n=170 Participants
|
77 Participants
n=242 Participants
|
115 Participants
n=338 Participants
|
19 Participants
n=70 Participants
|
30 Participants
n=140 Participants
|
30 Participants
n=137 Participants
|
12 Participants
n=46 Participants
|
27 Participants
n=95 Participants
|
21 Participants
n=92 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=12 Participants
|
4 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
10 Participants
n=16 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
526 Participants
n=1861 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=90 Participants
|
98 Participants
n=187 Participants
|
105 Participants
n=180 Participants
|
87 Participants
n=170 Participants
|
119 Participants
n=242 Participants
|
163 Participants
n=338 Participants
|
40 Participants
n=70 Participants
|
80 Participants
n=140 Participants
|
88 Participants
n=137 Participants
|
26 Participants
n=46 Participants
|
46 Participants
n=95 Participants
|
47 Participants
n=92 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=12 Participants
|
10 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
6 Participants
n=16 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
994 Participants
n=1861 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=90 Participants
|
35 Participants
n=187 Participants
|
35 Participants
n=180 Participants
|
24 Participants
n=170 Participants
|
46 Participants
n=242 Participants
|
60 Participants
n=338 Participants
|
11 Participants
n=70 Participants
|
30 Participants
n=140 Participants
|
19 Participants
n=137 Participants
|
8 Participants
n=46 Participants
|
22 Participants
n=95 Participants
|
24 Participants
n=92 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
341 Participants
n=1861 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=90 Participants
|
0 Participants
n=187 Participants
|
0 Participants
n=180 Participants
|
1 Participants
n=170 Participants
|
1 Participants
n=242 Participants
|
1 Participants
n=338 Participants
|
0 Participants
n=70 Participants
|
2 Participants
n=140 Participants
|
0 Participants
n=137 Participants
|
1 Participants
n=46 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
6 Participants
n=1861 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=90 Participants
|
20 Participants
n=187 Participants
|
21 Participants
n=180 Participants
|
13 Participants
n=170 Participants
|
10 Participants
n=242 Participants
|
8 Participants
n=338 Participants
|
2 Participants
n=70 Participants
|
6 Participants
n=140 Participants
|
13 Participants
n=137 Participants
|
5 Participants
n=46 Participants
|
3 Participants
n=95 Participants
|
2 Participants
n=92 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
113 Participants
n=1861 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=90 Participants
|
0 Participants
n=187 Participants
|
1 Participants
n=180 Participants
|
0 Participants
n=170 Participants
|
1 Participants
n=242 Participants
|
0 Participants
n=338 Participants
|
1 Participants
n=70 Participants
|
1 Participants
n=140 Participants
|
1 Participants
n=137 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=95 Participants
|
1 Participants
n=92 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
6 Participants
n=1861 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=90 Participants
|
32 Participants
n=187 Participants
|
31 Participants
n=180 Participants
|
23 Participants
n=170 Participants
|
39 Participants
n=242 Participants
|
65 Participants
n=338 Participants
|
10 Participants
n=70 Participants
|
35 Participants
n=140 Participants
|
25 Participants
n=137 Participants
|
8 Participants
n=46 Participants
|
23 Participants
n=95 Participants
|
23 Participants
n=92 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=12 Participants
|
9 Participants
n=15 Participants
|
3 Participants
n=15 Participants
|
3 Participants
n=16 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
350 Participants
n=1861 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=90 Participants
|
70 Participants
n=187 Participants
|
64 Participants
n=180 Participants
|
74 Participants
n=170 Participants
|
89 Participants
n=242 Participants
|
127 Participants
n=338 Participants
|
28 Participants
n=70 Participants
|
45 Participants
n=140 Participants
|
49 Participants
n=137 Participants
|
11 Participants
n=46 Participants
|
29 Participants
n=95 Participants
|
25 Participants
n=92 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
8 Participants
n=16 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
677 Participants
n=1861 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=90 Participants
|
0 Participants
n=187 Participants
|
0 Participants
n=180 Participants
|
0 Participants
n=170 Participants
|
0 Participants
n=242 Participants
|
0 Participants
n=338 Participants
|
0 Participants
n=70 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=92 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=1861 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=90 Participants
|
65 Participants
n=187 Participants
|
63 Participants
n=180 Participants
|
59 Participants
n=170 Participants
|
102 Participants
n=242 Participants
|
137 Participants
n=338 Participants
|
29 Participants
n=70 Participants
|
51 Participants
n=140 Participants
|
49 Participants
n=137 Participants
|
21 Participants
n=46 Participants
|
40 Participants
n=95 Participants
|
41 Participants
n=92 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=12 Participants
|
3 Participants
n=15 Participants
|
5 Participants
n=15 Participants
|
5 Participants
n=16 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=2 Participants
|
709 Participants
n=1861 Participants
|
|
CRP levels
|
192.537 milligrams per Liter (mg/L)
STANDARD_DEVIATION 122.295 • n=87 Participants • ITT population
|
191.997 milligrams per Liter (mg/L)
STANDARD_DEVIATION 124.583 • n=180 Participants • ITT population
|
195.037 milligrams per Liter (mg/L)
STANDARD_DEVIATION 119.274 • n=171 Participants • ITT population
|
167.476 milligrams per Liter (mg/L)
STANDARD_DEVIATION 115.020 • n=162 Participants • ITT population
|
187.573 milligrams per Liter (mg/L)
STANDARD_DEVIATION 108.085 • n=223 Participants • ITT population
|
179.085 milligrams per Liter (mg/L)
STANDARD_DEVIATION 103.837 • n=314 Participants • ITT population
|
111.933 milligrams per Liter (mg/L)
STANDARD_DEVIATION 81.789 • n=64 Participants • ITT population
|
127.811 milligrams per Liter (mg/L)
STANDARD_DEVIATION 116.058 • n=133 Participants • ITT population
|
129.355 milligrams per Liter (mg/L)
STANDARD_DEVIATION 136.734 • n=114 Participants • ITT population
|
205.978 milligrams per Liter (mg/L)
STANDARD_DEVIATION 118.459 • n=44 Participants • ITT population
|
235.395 milligrams per Liter (mg/L)
STANDARD_DEVIATION 280.665 • n=89 Participants • ITT population
|
232.924 milligrams per Liter (mg/L)
STANDARD_DEVIATION 128.435 • n=86 Participants • ITT population
|
141.207 milligrams per Liter (mg/L)
STANDARD_DEVIATION 71.915 • n=8 Participants • ITT population
|
203.356 milligrams per Liter (mg/L)
STANDARD_DEVIATION 118.998 • n=11 Participants • ITT population
|
185.740 milligrams per Liter (mg/L)
STANDARD_DEVIATION 91.237 • n=14 Participants • ITT population
|
226.846 milligrams per Liter (mg/L)
STANDARD_DEVIATION 112.047 • n=13 Participants • ITT population
|
212.920 milligrams per Liter (mg/L)
STANDARD_DEVIATION 107.702 • n=15 Participants • ITT population
|
177.334 milligrams per Liter (mg/L)
STANDARD_DEVIATION 79.490 • n=6 Participants • ITT population
|
258.081 milligrams per Liter (mg/L)
STANDARD_DEVIATION 200.704 • n=2 Participants • ITT population
|
180.010 milligrams per Liter (mg/L)
STANDARD_DEVIATION 131.909 • n=1736 Participants • ITT population
|
PRIMARY outcome
Timeframe: Baseline and Day 4Population: Phase 2 mITT population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of the study drug and have high baseline IL-6 levels.
Percent Change from Baseline in C-Reactive Protein (CRP) Levels at Day 4 in Participants with Serum Interleukin 6 (IL-6) Level Greater than the Upper Limit of Normal (ULN) Least Squares (LS) means estimate of percent change from baseline at Day 4 (raw scale) for each treatment group is based on the Analysis of Covariance (ANCOVA) model. It is defined as anti-log of the estimate of dependent variable minus 1, i.e., (exp\[ln(CRP at day 4/Baseline CRP)\]-1. Negative numbers imply improvement in CRP.
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=152 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=153 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=80 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2)
|
-0.77 Percent Change
Standard Error 0.018
|
-0.78 Percent Change
Standard Error 0.017
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.20 Percent Change
Standard Error 0.077
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 22Population: Phase 3 Cohort 1 Intention-to-treat (ITT) participants with a disease severity of critical and mechanical ventilation at baseline.
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 1-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale in Participants With Critical COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 1)
|
43.3 Percentage of participants
Interval 33.7 to 52.8
|
43.2 Percentage of participants
Interval 34.7 to 51.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
35.5 Percentage of participants
Interval 23.6 to 47.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 22Population: Phase 3 Cohort 2 ITT participants receiving mechanical ventilation at baseline
The ordinal scale is an assessment of the clinical status of a participant The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=16 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 2)
|
68.8 Percentage of participants
Interval 46.0 to 91.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
60.0 Percentage of participants
Interval 35.2 to 84.8
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Phase 2 mITT population: The modified intention-to-treat (mITT) population includes all randomized participants who received at least one dose of the study drug and have high baseline IL-6 levels.
Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical participants with serum IL-6 levels greater than the upper limit of normal (ULN). The ordinal scale is an assessment of the clinical status of a patient. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=117 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=120 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With Serum IL-6 Levels Greater Than the Upper Limit of Normal (Phase 2)
|
15.0 Days
Interval 12.0 to 21.0
|
14.0 Days
Interval 10.0 to 21.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16.0 Days
Interval 11.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Phase 2 Severe and Critical ITT population. The intention-to-treat (ITT) population includes all randomized patients who received at least one dose of the study drug.
Time to improvement (2 points) in clinical status assessment on the 7-point ordinal scale in severe or critical participants with all serum IL-6 levels. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=144 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=139 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=69 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Improvement (2 Points) in Clinical Status Assessment in Severe or Critical Patients With All Serum IL-6 Levels (Phase 2)
|
14.0 Days
Interval 11.0 to 19.0
|
13.0 Days
Interval 10.0 to 18.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
15.0 Days
Interval 10.0 to 28.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Phase 2 ITT population with presence of fever at baseline
Time to resolution of fever for at least 48 hours without antipyretics or until discharge, whichever is sooner, in patients with documented fever ≥38°C (oral), ≥38.4°C (rectal or tympanic), or ≥37.6°C (temporal or axillary) at Baseline. Resolution of fever is defined as postbaseline body temperature \<37.2°C (oral), or \<37.6°C (rectal or tympanic) or \<36.8°C (temporal or axillary).
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=114 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=117 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=50 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, in Patients With Documented Fever at Baseline (Phase 2)
|
18.0 Days
Interval 11.0 to
Less than 50% of participants experienced an event response
|
18.0 Days
Interval 11.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17.0 Days
Interval 11.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 2 ITT population with presence of fever at baseline
Resolution of fever is defined as body temperature \<=36.8 C (axilla or temporal) or\<= 37.2 C (oral) or \<37.6 C (rectal or tympanic) for at least 48 hours without antipyretics or until discharge. Resolution of fever is defined only in participants with presence of fever at baseline.
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=114 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=117 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=50 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2)
Disease Severity: Severe
|
5.0 Days
Interval 3.0 to 8.0
|
6.0 Days
Interval 5.0 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.0 Days
Interval 4.0 to 10.0
|
—
|
—
|
—
|
|
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2)
Disease Severity: Critical
|
29.0 Days
Interval 16.0 to
Less than 50% of participants experienced an event response
|
20.5 Days
Interval 11.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Days
Interval 15.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
|
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics by Clinical Severity (Phase 2)
Disease Severity: Multisystem Organ Dysfunction
|
NA Days
Interval 17.0 to
Less than 50% of participants experienced an event response
|
NA Days
Interval 18.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Days
Interval 11.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Phase 2 ITT population with presence of fever and IL-6 measurement reported at baseline
Resolution of fever is defined as body temperature \<=36.8 C (axilla or temporal) or\<= 37.2 C (oral) or \<37.6 C (rectal or tympanic) for at least 48 hours without antipyretics or until discharge, by baseline IL-6 levels. Resolution of fever is defined only in participants with presence of fever at baseline.
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=102 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=48 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2)
Disease Severity: MSOD Baseline IL-6 >= 254.95 pg/mL (Median)
|
NA Days
Interval 2.0 to
Less than 50% of participants experienced an event response
|
NA Days
Interval 5.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Days
Interval 11.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
|
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2)
Disease Severity: Severe Baseline IL-6 < 87.04 picograms per milliliter (pg/mL) Median
|
5.0 Days
Interval 3.0 to 7.0
|
5.0 Days
Interval 3.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.5 Days
Interval 4.0 to 12.0
|
—
|
—
|
—
|
|
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2)
Disease Severity: Severe Baseline IL-6 >= 87.04pg/mL (Median)
|
8.0 Days
Interval 3.0 to 12.0
|
NA Days
Interval 4.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.0 Days
Interval 3.0 to 8.0
|
—
|
—
|
—
|
|
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2)
Disease Severity: Critical Baseline IL-6 < 166.68pg/mL (Median)
|
16.5 Days
Interval 5.0 to
Less than 50% of participants experienced an event response
|
17.0 Days
Interval 5.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.0 Days
Interval 2.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
|
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2)
Disease Severity: Critical Baseline IL-6 >= 166.68pg/mL (Median)
|
NA Days
Interval 16.0 to
Less than 50% of participants experienced an event response
|
25.0 Days
Interval 12.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Days
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
|
Time to Resolution of Fever for at Least 48 Hours Without Antipyretics or Until Discharge, Whichever is Sooner, by Baseline IL-6 Levels (Phase 2)
Disease Severity: MSOD Baseline IL-6 <254.95 pg/mL (Median)
|
NA Days
Interval 9.0 to
Less than 50% of participants experienced an event response
|
NA Days
Interval 15.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Days
Interval 14.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 2 ITT population
Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2)
Disease Severity: Severe
|
6.0 Days
Interval 5.0 to 9.0
|
11.0 Days
Interval 6.0 to
Less than 50% of participants experience the event
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.0 Days
Interval 5.0 to 9.0
|
—
|
—
|
—
|
|
Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2)
Disease Severity: Critical
|
20.0 Days
Interval 12.0 to
Less than 50% of participants experience the event
|
11.0 Days
Interval 8.0 to 15.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.5 Days
Interval 7.0 to
Less than 50% of participants experience the event
|
—
|
—
|
—
|
|
Time to Improvement in Oxygenation for at Least 48 Hours (Phase 2)
Disease Severity: MSOD
|
NA Days
Interval 12.0 to
Less than 50% of participants experience the event
|
19.0 Days
Interval 10.0 to
Less than 50% of participants experience the event
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20.0 Days
Interval 9.0 to
Less than 50% of participants experience the event
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 2 ITT population with IL-6 measurement reported at baseline
Time to Improvement defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=167 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=160 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=82 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2)
Severe Participants Baseline IL-6 < 67.11pg/mL (median)
|
5.0 Days
Interval 4.0 to 7.0
|
7.5 Days
Interval 4.0 to
Less than 50% of participants experienced an event
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.0 Days
Interval 2.0 to 12.0
|
—
|
—
|
—
|
|
Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2)
Severe Participants Baseline IL-6 >= 67.11pg/mL (median)
|
8.5 Days
Interval 5.0 to 11.0
|
NA Days
Interval 11.0 to
Less than 50% of participants experienced an event
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.5 Days
Interval 4.0 to 9.0
|
—
|
—
|
—
|
|
Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2)
Critical Participants Baseline IL-6 < 131.90pg/mL (median)
|
17.0 Days
Interval 8.0 to
Less than 50% of participants experienced an event
|
8.5 Days
Interval 7.0 to 15.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.0 Days
Interval 6.0 to
Less than 50% of participants experienced an event
|
—
|
—
|
—
|
|
Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2)
Critical Participants Baseline IL-6 >= 131.90pg/mL (median)
|
NA Days
Interval 12.0 to
Less than 50% of participants experienced an event
|
14.0 Days
Interval 8.0 to
Less than 50% of participants experienced an event
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
15.0 Days
Interval 6.0 to
Less than 50% of participants experienced an event
|
—
|
—
|
—
|
|
Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2)
MSOD / Immunocompromised Participants Baseline IL-6 < 254.95pg/mL (median)
|
NA Days
Interval 7.0 to
Less than 50% of participants experienced an event
|
24.0 Days
Interval 7.0 to
Less than 50% of participants experienced an event
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.0 Days
Interval 3.0 to
Less than 50% of participants experienced an event
|
—
|
—
|
—
|
|
Time to Improvement in Oxygenation for at Least 48 Hours by Baseline IL-6 Levels (Phase 2)
MSOD / Immunocompromised Participants Baseline IL-6 >= 254.95pg/mL (median)
|
NA Days
Interval 8.0 to
Less than 50% of participants experienced an event
|
19.0 Days
Interval 13.0 to
Less than 50% of participants experienced an event
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
24.0 Days
Interval 9.0 to
Less than 50% of participants experienced an event
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 2 ITT population
Resolution of fever defined as postbaseline body temperature \<37.2°C (oral), or \<37.6°C (rectal or tympanic) or \<36.8°C (temporal or axillary) Improvement in oxygenation defined as increase in SpO2/FiO2 of 50 or greater compared to the nadir SpO2/FiO2
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2)
Disease Severity: Severe
|
4.0 Days
Interval 3.0 to 8.0
|
6.0 Days
Interval 4.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.0 Days
Interval 4.0 to 7.0
|
—
|
—
|
—
|
|
Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2)
Disease Severity: Critical
|
22.0 Days
Interval 8.0 to
Less than 50% of participants experienced an event response
|
8.5 Days
Interval 7.0 to 14.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
15.0 Days
Interval 7.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
|
Time to Resolution of Fever and Improvement in Oxygenation for at Least 48 Hours (Phase 2)
Disease Severity: MSOD
|
NA Days
Interval 9.0 to
Less than 50% of participants experienced an event response
|
24.0 Days
Interval 9.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20.0 Days
Interval 8.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: Phase 2 ITT population
Percentage of participants in each clinical status category using the 7-point ordinal scale from Baseline (Day 1) up to Day 29. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 5 Ordinal Scale = 3
|
8.5 Percentage of Participants
|
9.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11.4 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 1 Ordinal Scale = 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 1 Ordinal Scale = 2
|
0 Percentage of Participants
|
7.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 1 Ordinal Scale = 3
|
2.0 Percentage of Participants
|
3.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 1 Ordinal Scale = 4
|
94.0 Percentage of Participants
|
88.2 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 1 Ordinal Scale = 5
|
4.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 1 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 1 Ordinal Scale = 7
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 3 Ordinal Scale = 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 3 Ordinal Scale = 2
|
4.0 Percentage of Participants
|
13.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 3 Ordinal Scale = 3
|
6.0 Percentage of Participants
|
5.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 3 Ordinal Scale = 4
|
88.0 Percentage of Participants
|
72.5 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
96.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 3 Ordinal Scale = 5
|
2.0 Percentage of Participants
|
3.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 3 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 3 Ordinal Scale = 7
|
0 Percentage of Participants
|
3.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 5 Ordinal Scale = 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 5 Ordinal Scale = 2
|
6.0 Percentage of Participants
|
21.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 5 Ordinal Scale = 3
|
8.0 Percentage of Participants
|
3.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 5 Ordinal Scale = 4
|
66.0 Percentage of Participants
|
49.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
72.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 5 Ordinal Scale = 5
|
4.0 Percentage of Participants
|
11.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 5 Ordinal Scale = 6
|
2.0 Percentage of Participants
|
2.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 5 Ordinal Scale = 7
|
14.0 Percentage of Participants
|
11.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 8 Ordinal Scale = 1
|
2.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 8 Ordinal Scale = 2
|
4.0 Percentage of Participants
|
19.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 8 Ordinal Scale = 3
|
8.0 Percentage of Participants
|
5.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 8 Ordinal Scale = 4
|
34.0 Percentage of Participants
|
29.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
48.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 8 Ordinal Scale = 5
|
6.0 Percentage of Participants
|
2.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 8 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 8 Ordinal Scale = 7
|
46.0 Percentage of Participants
|
43.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
40.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 11 Ordinal Scale = 1
|
2.0 Percentage of Participants
|
11.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 11 Ordinal Scale = 2
|
4.0 Percentage of Participants
|
11.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 11 Ordinal Scale = 3
|
6.0 Percentage of Participants
|
3.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 11 Ordinal Scale = 4
|
14.0 Percentage of Participants
|
9.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
32.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 11 Ordinal Scale = 5
|
0 Percentage of Participants
|
2.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 11 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 11 Ordinal Scale = 7
|
74.0 Percentage of Participants
|
60.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
56.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 15 Ordinal Scale = 1
|
4.0 Percentage of Participants
|
15.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 15 Ordinal Scale = 2
|
2.0 Percentage of Participants
|
9.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 15 Ordinal Scale = 3
|
2.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 15 Ordinal Scale = 4
|
6.0 Percentage of Participants
|
5.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 15 Ordinal Scale = 5
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 15 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 15 Ordinal Scale = 7
|
86.0 Percentage of Participants
|
68.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
76.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 29 Ordinal Scale = 1
|
4.0 Percentage of Participants
|
17.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 29 Ordinal Scale = 2
|
2.0 Percentage of Participants
|
7.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 29 Ordinal Scale = 3
|
0 Percentage of Participants
|
2.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 29 Ordinal Scale = 4
|
2.0 Percentage of Participants
|
2.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 29 Ordinal Scale = 5
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 29 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Severe Day 29 Ordinal Scale = 7
|
92.0 Percentage of Participants
|
70.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
92.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 1 Ordinal Scale = 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 1 Ordinal Scale = 2
|
64.9 Percentage of Participants
|
54.5 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
40.9 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 1 Ordinal Scale = 3
|
6.4 Percentage of Participants
|
6.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.1 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 1 Ordinal Scale = 4
|
28.7 Percentage of Participants
|
38.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
50.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 1 Ordinal Scale = 5
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 1 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 1 Ordinal Scale = 7
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 3 Ordinal Scale = 1
|
3.2 Percentage of Participants
|
1.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 3 Ordinal Scale = 2
|
71.3 Percentage of Participants
|
56.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
59.1 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 3 Ordinal Scale = 3
|
6.4 Percentage of Participants
|
10.2 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.1 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 3 Ordinal Scale = 4
|
19.1 Percentage of Participants
|
28.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
31.8 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 3 Ordinal Scale = 5
|
0 Percentage of Participants
|
1.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 3 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 3 Ordinal Scale = 7
|
0 Percentage of Participants
|
1.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 3 Ordinal Scale = Missing
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.8 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 5 Ordinal Scale = 1
|
9.6 Percentage of Participants
|
4.5 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 5 Ordinal Scale = 2
|
64.9 Percentage of Participants
|
53.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
52.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 5 Ordinal Scale = 4
|
14.9 Percentage of Participants
|
28.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
34.1 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 5 Ordinal Scale = 5
|
0 Percentage of Participants
|
2.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 5 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 5 Ordinal Scale = 7
|
2.1 Percentage of Participants
|
2.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 8 Ordinal Scale = 1
|
20.2 Percentage of Participants
|
9.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.8 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 8 Ordinal Scale = 2
|
50.0 Percentage of Participants
|
46.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
43.2 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 8 Ordinal Scale = 3
|
5.3 Percentage of Participants
|
1.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.8 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 8 Ordinal Scale = 4
|
16.0 Percentage of Participants
|
27.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
29.5 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 8 Ordinal Scale = 5
|
1.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 8 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 8 Ordinal Scale = 7
|
7.4 Percentage of Participants
|
15.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.6 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 11 Ordinal Scale = 1
|
21.3 Percentage of Participants
|
11.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.1 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 11 Ordinal Scale = 2
|
41.5 Percentage of Participants
|
37.5 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
45.5 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 11 Ordinal Scale = 3
|
6.4 Percentage of Participants
|
2.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 11 Ordinal Scale = 4
|
11.7 Percentage of Participants
|
19.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20.5 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 11 Ordinal Scale = 5
|
2.1 Percentage of Participants
|
2.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 11 Ordinal Scale = 6
|
0 Percentage of Participants
|
1.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 11 Ordinal Scale = 7
|
17.0 Percentage of Participants
|
26.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
25.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 15 Ordinal Scale = 1
|
27.7 Percentage of Participants
|
13.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
18.2 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 15 Ordinal Scale = 2
|
24.5 Percentage of Participants
|
29.5 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
36.4 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 15 Ordinal Scale = 3
|
3.2 Percentage of Participants
|
1.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 15 Ordinal Scale = 2
|
34.9 Percentage of Participants
|
51.2 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
38.1 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 15 Ordinal Scale = 3
|
2.3 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 15 Ordinal Scale = 4
|
19.1 Percentage of Participants
|
14.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.6 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 15 Ordinal Scale = 5
|
3.2 Percentage of Participants
|
1.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 15 Ordinal Scale = 6
|
1.1 Percentage of Participants
|
1.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 15 Ordinal Scale = 7
|
21.3 Percentage of Participants
|
38.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
31.8 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 29 Ordinal Scale = 1
|
37.2 Percentage of Participants
|
25.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
27.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 29 Ordinal Scale = 2
|
7.4 Percentage of Participants
|
5.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
27.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 29 Ordinal Scale = 3
|
2.1 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 29 Ordinal Scale = 4
|
4.3 Percentage of Participants
|
9.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.5 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 29 Ordinal Scale = 5
|
2.1 Percentage of Participants
|
3.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 29 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: Critical Day 29 Ordinal Scale = 7
|
46.8 Percentage of Participants
|
56.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
40.9 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 1 Ordinal Scale = 1
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 1 Ordinal Scale = 2
|
100 Percentage of Participants
|
100 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 1 Ordinal Scale = 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 1 Ordinal Scale = 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 1 Ordinal Scale = 5
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 1 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 1 Ordinal Scale = 7
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 3 Ordinal Scale = 1
|
4.7 Percentage of Participants
|
2.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 3 Ordinal Scale = 2
|
95.3 Percentage of Participants
|
97.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 3 Ordinal Scale = 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 3 Ordinal Scale = 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 3 Ordinal Scale = 5
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 3 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 3 Ordinal Scale = 7
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 5 Ordinal Scale = 1
|
9.3 Percentage of Participants
|
14.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.5 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 5 Ordinal Scale = 2
|
88.4 Percentage of Participants
|
82.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
90.5 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 5 Ordinal Scale = 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 5 Ordinal Scale = 4
|
2.3 Percentage of Participants
|
2.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 5 Ordinal Scale = 5
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 5 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 5 Ordinal Scale = 7
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 8 Ordinal Scale = 1
|
14.0 Percentage of Participants
|
19.5 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
19.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 8 Ordinal Scale = 2
|
69.8 Percentage of Participants
|
75.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
71.4 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 8 Ordinal Scale = 3
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.5 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 8 Ordinal Scale = 4
|
14.0 Percentage of Participants
|
4.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 8 Ordinal Scale = 5
|
2.3 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 8 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 8 Ordinal Scale = 7
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 11 Ordinal Scale = 1
|
25.6 Percentage of Participants
|
26.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
19.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 11 Ordinal Scale = 2
|
46.5 Percentage of Participants
|
61.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
66.7 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 11 Ordinal Scale = 3
|
4.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.8 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 11 Ordinal Scale = 4
|
11.6 Percentage of Participants
|
7.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.5 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 11 Ordinal Scale = 5
|
4.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 11 Ordinal Scale = 6
|
2.3 Percentage of Participants
|
2.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 11 Ordinal Scale = 7
|
4.7 Percentage of Participants
|
2.4 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 15 Ordinal Scale = 1
|
34.9 Percentage of Participants
|
31.7 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
23.8 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 15 Ordinal Scale = 4
|
2.3 Percentage of Participants
|
9.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
33.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 15 Ordinal Scale = 5
|
7.0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 15 Ordinal Scale = 6
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 15 Ordinal Scale = 7
|
18.6 Percentage of Participants
|
7.3 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.8 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 29 Ordinal Scale = 1
|
41.9 Percentage of Participants
|
39.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
33.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 29 Ordinal Scale = 2
|
14.0 Percentage of Participants
|
14.6 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
19.0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 29 Ordinal Scale = 3
|
2.3 Percentage of Participants
|
4.9 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 29 Ordinal Scale = 4
|
2.3 Percentage of Participants
|
9.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.5 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 29 Ordinal Scale = 5
|
7.0 Percentage of Participants
|
9.8 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 29 Ordinal Scale = 6
|
4.7 Percentage of Participants
|
0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 29 Ordinal Scale = 7
|
27.9 Percentage of Participants
|
22.0 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
33.3 Percentage of Participants
|
—
|
—
|
—
|
|
Percentage of Participants in Each Clinical Status Category Using the 7-point Ordinal Scale up to Day 29 (Phase 2)
Disease Severity: MSOD Day 29 Ordinal Scale = Missing
|
0 Percentage of Participants
|
1.1 Percentage of Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Percentage of Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 2 ITT population
NEWS2 was used to standardize assessment of acute-illness severity, track clinical condition of participants and to alert clinical teams to participant deterioration. NEWS2 score was based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (a score of 0 or 1 was allocated) and level of consciousness (a score of 0 or 3 was allocated), where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS2 score ranged from 0 to 19, with higher scores meaning more severity/higher risk: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19).
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2)
Disease Severity: Severe
|
6.0 Days
Interval 4.0 to 7.0
|
6.0 Days
Interval 4.0 to 7.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.0 Days
Interval 4.0 to 8.0
|
—
|
—
|
—
|
|
Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2)
Disease Severity: Critical
|
25.0 Days
Interval 19.0 to
Less than 50% of participants experienced an event response
|
15.0 Days
Interval 10.0 to 20.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Days
Interval 9.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
|
Time to Discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and Maintained for 24 Hours (Phase 2)
Disease Severity: MSOD
|
NA Days
Interval 24.0 to
Less than 50% of participants experienced an event response
|
NA Days
Interval 23.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Days
Interval 18.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 3, 5, 8, 11, 15 and 29Population: Phase 2 ITT population with NEWS2 score reported at baseline
NEWS2 was used to standardize assessment of acute-illness severity, track clinical condition of participants and to alert clinical teams to participant deterioration. NEWS2 score was based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure, pulse rate, level of consciousness, and temperature. A score of 0, 1, 2, and 3 was allocated to each parameter except supplemental oxygen (a score of 0 or 1 was allocated) and level of consciousness (a score of 0 or 3 was allocated), where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS2 score ranged from 0 to 19, with higher scores meaning more severity/higher risk: low risk (score 0 to 4); low to medium risk (score of 3 in any individual parameter); medium risk (score 5 to 6); high risk (score 7 to 19).
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=151 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=147 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=72 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in NEWS2 Scoring System (Phase 2)
Day 3
|
0.14 scores on a scale
Standard Deviation 2.69
|
0.03 scores on a scale
Standard Deviation 3.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.46 scores on a scale
Standard Deviation 2.29
|
—
|
—
|
—
|
|
Change From Baseline in NEWS2 Scoring System (Phase 2)
Day 5
|
0.00 scores on a scale
Standard Deviation 2.98
|
0.03 scores on a scale
Standard Deviation 3.26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.36 scores on a scale
Standard Deviation 3.18
|
—
|
—
|
—
|
|
Change From Baseline in NEWS2 Scoring System (Phase 2)
Day 8
|
-0.22 scores on a scale
Standard Deviation 3.33
|
-0.31 scores on a scale
Standard Deviation 3.65
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.17 scores on a scale
Standard Deviation 3.05
|
—
|
—
|
—
|
|
Change From Baseline in NEWS2 Scoring System (Phase 2)
Day 11
|
-0.27 scores on a scale
Standard Deviation 3.65
|
-0.29 scores on a scale
Standard Deviation 4.29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.00 scores on a scale
Standard Deviation 3.53
|
—
|
—
|
—
|
|
Change From Baseline in NEWS2 Scoring System (Phase 2)
Day 15
|
-0.45 scores on a scale
Standard Deviation 3.91
|
-0.48 scores on a scale
Standard Deviation 4.50
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.40 scores on a scale
Standard Deviation 3.55
|
—
|
—
|
—
|
|
Change From Baseline in NEWS2 Scoring System (Phase 2)
Day 29
|
-1.12 scores on a scale
Standard Deviation 4.23
|
-1.34 scores on a scale
Standard Deviation 4.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
-0.67 scores on a scale
Standard Deviation 4.12
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Phase 2 ITT population
Defined as ≥38°C (oral), ≥38.4°C (rectal or tympanic) or ≥37.6°C (temporal or axillary)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Days With Fever (Phase 2)
|
4.2 Days
Standard Deviation 4.37
|
5.8 Days
Standard Deviation 7.49
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.3 Days
Standard Deviation 5.92
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 29Population: Phase 2 ITT population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Alive, Off Oxygen (Phase 2)
Disease Severity: Severe
|
92.0 percentage of participants
Interval 84.5 to 99.5
|
70.6 percentage of participants
Interval 58.1 to 83.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
92.0 percentage of participants
Interval 81.4 to 100.0
|
—
|
—
|
—
|
|
Percentage of Participants Alive, Off Oxygen (Phase 2)
Disease Severity: Critical
|
50.0 percentage of participants
Interval 39.9 to 60.1
|
61.4 percentage of participants
Interval 51.2 to 71.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
40.9 percentage of participants
Interval 26.4 to 55.4
|
—
|
—
|
—
|
|
Percentage of Participants Alive, Off Oxygen (Phase 2)
Disease Severity: MSOD
|
39.5 percentage of participants
Interval 24.9 to 54.1
|
34.1 percentage of participants
Interval 19.6 to 48.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
38.1 percentage of participants
Interval 17.3 to 58.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 2 ITT population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Days of Resting Respiratory Rate >24 Breaths/Min (Phase 2)
|
7.3 Days
Standard Deviation 8.21
|
8.2 Days
Standard Deviation 7.99
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9.2 Days
Standard Deviation 10.29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 2 ITT population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Days With Hypoxemia (Phase 2)
|
14.5 Days
Standard Deviation 11.96
|
16.4 Days
Standard Deviation 13.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
18.1 Days
Standard Deviation 14.16
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 2 ITT population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Days of Supplemental Oxygen Use (Phase 2)
|
14.1 days
Standard Deviation 11.92
|
16.2 days
Standard Deviation 14.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17.7 days
Standard Deviation 14.15
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 2 ITT population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Saturation ≥94% on Room Air (Phase 2)
Disease Severity: Severe
|
NA Days
Less than 50% of participants experienced an event response
|
NA Days
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Days
Interval 6.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
|
Time to Saturation ≥94% on Room Air (Phase 2)
Disease Severity: Critical
|
NA Days
Interval 5.0 to
Less than 50% of participants experienced an event response
|
NA Days
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Days
Interval 3.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
|
Time to Saturation ≥94% on Room Air (Phase 2)
Disease Severity: MSOD
|
NA Days
Interval 4.0 to
Less than 50% of participants experienced an event response
|
NA Days
Interval 4.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
5.0 Days
Interval 2.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 22Population: Phase 2 ITT population
Summary of Ventilator-free days during study in Participants using Invasive Mechanical Ventilation at Baseline
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Ventilator Free Days (Phase 2)
Disease Severity: Severe
|
19.7 Days
Standard Deviation 4.7
|
15.5 Days
Standard Deviation 9.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
19.9 Days
Standard Deviation 4.2
|
—
|
—
|
—
|
|
Number of Ventilator Free Days (Phase 2)
Disease Severity: Critical
|
7.6 Days
Standard Deviation 8.5
|
10.9 Days
Standard Deviation 9.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.9 Days
Standard Deviation 9.6
|
—
|
—
|
—
|
|
Number of Ventilator Free Days (Phase 2)
Disease Severity: MSOD
|
4.6 Days
Standard Deviation 6.5
|
3.3 Days
Standard Deviation 5.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.5 Days
Standard Deviation 5.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Phase 2 ITT population not on Invasive mechanical ventilation or ECMO at baseline
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2)
Disease Severity: Severe
|
4 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2)
Disease Severity: Critical
|
14 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13 Participants
|
—
|
—
|
—
|
|
Number of Participants Who Initiated Mechanical Ventilation After Baseline (Phase 2)
Disease Severity: MSOD
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29Population: Phase 2 ITT population participants who were not in ICU at baseline
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=67 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=39 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Days in an Intensive Care Unit (ICU) in Participants Who Were Not in ICU at Baseline (Phase 2)
|
11.4 Days
Standard Deviation 10.5
|
13.8 Days
Standard Deviation 15.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.6 Days
Standard Deviation 11.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 2 ITT population participants with a hospital discharge date on or before Day 29
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=127 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=131 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=66 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Days of Hospitalization Among Survivors (Phase 2)
Up to Day 8
|
7.3 days
Standard Deviation 1.3
|
7.2 days
Standard Deviation 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.3 days
Standard Deviation 1.3
|
—
|
—
|
—
|
|
Number of Days of Hospitalization Among Survivors (Phase 2)
Up to Day 15
|
13.5 days
Standard Deviation 2.2
|
13.5 days
Standard Deviation 2.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.7 days
Standard Deviation 2.0
|
—
|
—
|
—
|
|
Number of Days of Hospitalization Among Survivors (Phase 2)
Up to Day 22
|
21.2 days
Standard Deviation 1.7
|
21.6 days
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
21.3 days
Standard Deviation 1.8
|
—
|
—
|
—
|
|
Number of Days of Hospitalization Among Survivors (Phase 2)
Up to Day 29
|
27.5 days
Standard Deviation 2.2
|
28.4 days
Standard Deviation 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
27.3 days
Standard Deviation 2.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 60Population: ITT population
Number of deaths due to any cause (All-Cause Mortality)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=170 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=8 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=12 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Deaths Due to Any Cause
|
60 deaths
|
49 deaths
|
59 deaths
|
70 deaths
|
114 deaths
|
9 deaths
|
12 deaths
|
21 deaths
|
16 deaths
|
40 deaths
|
40 deaths
|
3 deaths
|
4 deaths
|
6 deaths
|
4 deaths
|
24 deaths
|
3 deaths
|
1 deaths
|
0 deaths
|
SECONDARY outcome
Timeframe: Day 22Population: Phase 3 Cohort 1 Critical ITT population
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With Critical COVID-19 (Phase 3 Cohort 1: Critical ITT)
|
56.6 Percentage of Participants
Interval 50.4 to 62.9
|
51.5 Percentage of Participants
Interval 46.2 to 56.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
54.1 Percentage of Participants
Interval 46.6 to 61.6
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22Population: Phase 3 Cohort 1 Critical population receiving mechanical ventilation at baseline
Percentage of Participants Who Recover (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) at Day 22
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
|
30.8 Percentage of Participants
Interval 21.9 to 39.6
|
31.8 Percentage of Participants
Interval 23.9 to 39.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
25.8 Percentage of Participants
Interval 14.9 to 36.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22Population: Phase 3 Cohort 1 Critical ITT
Percentage of Participants Who Recover (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use) at Day 22
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Recover (Phase 3 Cohort 1: Critical ITT)
|
49.6 Percentage of Participants
Interval 43.3 to 55.9
|
45.3 Percentage of Participants
Interval 40.0 to 50.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
50.0 Percentage of Participants
Interval 42.5 to 57.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29 and Day 60Population: Phase 3 Cohort 1 Critical population receiving mechanical ventilation at baseline
Percentage of Participants who die through Day 29 and Day 60
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Through Day 29
|
33.7 Percentage of Participants
Interval 24.6 to 42.7
|
36.4 Percentage of Participants
Interval 28.2 to 44.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
41.9 Percentage of Participants
Interval 29.7 to 54.2
|
—
|
—
|
—
|
|
Percentage of Participants Who Die (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Through Day 60
|
37.5 Percentage of Participants
Interval 28.2 to 46.8
|
39.4 Percentage of Participants
Interval 31.1 to 47.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
51.6 Percentage of Participants
Interval 39.2 to 64.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 29 and Day 60Population: Phase 3 Cohort 1 Critical ITT population
Percentage of Participants who die through Day 29 and Day 60
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT)
Through Day 29
|
24.8 Percentage of Participants
Interval 19.4 to 30.2
|
30.5 Percentage of Participants
Interval 25.6 to 35.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
25.3 Percentage of Participants
Interval 18.8 to 31.8
|
—
|
—
|
—
|
|
Percentage of Participants Who Die (Phase 3 Cohort 1: Critical ITT)
Through Day 60
|
28.9 Percentage of Participants
Interval 23.2 to 34.6
|
33.7 Percentage of Participants
Interval 28.7 to 38.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
34.7 Percentage of Participants
Interval 27.6 to 41.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 22Population: Phase 3 Cohort 1 - Critical population receiving mechanical ventilation at baseline
Percentage of participants alive not receiving mechanical ventilation or ECMO at Day 22 (Phase 3 Cohort 1)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
|
46.2 Percentage of Participants
Interval 36.6 to 55.7
|
44.7 Percentage of Participants
Interval 36.2 to 53.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
35.5 Percentage of Participants
Interval 23.6 to 47.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 22Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
Percentage of participants with at least a 2-point improvement in clinical status from baseline to Day 22 using the 7-point ordinal scale. The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
|
38.5 Percentage of Participants
Interval 29.1 to 47.8
|
40.2 Percentage of Participants
Interval 31.8 to 48.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
33.9 Percentage of Participants
Interval 22.1 to 45.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 22Population: Phase 3 Cohort 1: Critical ITT population
Percentage of participants alive not receiving mechanical ventilation or ECMO at Day 22 (Phase 3 Cohort 1)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Alive Not Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT)
|
63.6 Percentage of Participants
Interval 57.6 to 69.7
|
55.9 Percentage of Participants
Interval 50.6 to 61.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
58.8 Percentage of Participants
Interval 51.4 to 66.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 22Population: Phase 3 Cohort 1: Critical ITT population
Percentage of participants with at least a 2-point improvement in clinical status from baseline to Day 22 using the 7-point ordinal scale. The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 2-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT)
|
52.5 Percentage of Participants
Interval 46.2 to 58.8
|
47.6 Percentage of Participants
Interval 42.3 to 53.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
52.4 Percentage of Participants
Interval 44.8 to 59.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 3 Cohort 1 Critical populations receiving mechanical ventilation at baseline
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
|
27.0 Days
Interval 18.0 to
Less than 50% of participants experienced an event response
|
NA Days
Interval 18.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Days
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 3 Cohort 1 Critical ITT population
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT)
|
16.0 Days
Interval 12.0 to 20.0
|
18.0 Days
Interval 14.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
19.5 Days
Interval 13.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 3 Cohort 2 Critical population receiving mechanical ventilation at baseline
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=16 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to at Least 1-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 2)
|
15.0 Days
Interval 9.0 to 25.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17.0 Days
Interval 6.0 to 26.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1)
|
NA days
Interval 21.0 to
Less than 50% of participants experienced an event response
|
NA days
Interval 21.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA days
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 3 Cohort 1: Critical ITT population
The ordinal scale is an assessment of the clinical status of a participant. The 7-point ordinal scale is as follows: 1\. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7. Not hospitalized; higher score = less severity
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to at Least 2-point Improvement in Clinical Status Assessment on the 7-point Ordinal Scale (Phase 3 Cohort 1: Critical ITT)
|
19.0 days
Interval 16.0 to 24.0
|
23.0 days
Interval 18.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
22.0 days
Interval 16.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
|
24.0 Percentage of Participants
Interval 15.8 to 32.3
|
23.5 Percentage of Participants
Interval 16.3 to 30.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
25.8 Percentage of Participants
Interval 14.9 to 36.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22Population: Phase 3 Cohort 1: Critical ITT population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Receiving Mechanical Ventilation or ECMO at Day 22 (Phase 3 Cohort 1: Critical ITT)
|
15.7 Percentage of Participants
Interval 11.1 to 20.3
|
17.5 Percentage of Participants
Interval 13.4 to 21.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
17.1 Percentage of Participants
Interval 11.4 to 22.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 22Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
Percentage of Patients Discharged and Alive at Day 22
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Discharged and Alive (Phase 3 Cohort 1)
|
26.9 Percentage of Participants
Interval 18.4 to 35.4
|
26.5 Percentage of Participants
Interval 19.0 to 34.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
22.6 Percentage of Participants
Interval 12.2 to 33.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 22Population: Phase 3 Cohort 1: Critical ITT population
Percentage of Participants Discharged and Alive at Day 22
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Discharged and Alive at Day 22 (Phase 3 Cohort 1: Critical ITT)
|
47.5 Percentage of Participants
Interval 41.2 to 53.8
|
42.6 Percentage of Participants
Interval 37.3 to 47.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
47.6 Percentage of Participants
Interval 40.1 to 55.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 3 Cohort 1 Critical population receiving mechanical ventilation at baseline
Phase 3 Cohort 1 Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Recovery (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
|
NA days
Interval 29.0 to
Less than 50% of participants experienced an event response
|
NA days
Interval 28.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA days
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 3 Cohort 1: Critical ITT population
Phase 3 Cohort 1 Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Recovery (Phase 3 Cohort 1: Critical ITT)
|
23.0 days
Interval 17.0 to
Less than 50% of participants experienced an event response
|
27.0 days
Interval 22.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
25.5 days
Interval 18.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 29Population: Phase 3 Cohort 2 population receiving mechanical ventilation at baseline
Time to Recovery (Discharged, or Alive without Supplemental Oxygen Use or at Pre-COVID Oxygen Use)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=16 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Recovery (Phase 3 Cohort 2)
|
22.0 days
Interval 13.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
23.0 days
Interval 12.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 60Population: Phase 3 Cohort 1 Critical population receiving mechanical ventilation at baseline
Phase 3 Cohort 1 Time to Death (All-Cause Mortality)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Death (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
|
NA days
Less than 50% of participants experienced an event response
|
NA days
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
41.0 days
Interval 17.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 60Population: Phase 3 Cohort 1: Critical ITT population
Time to Death (All-Cause Mortality)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Death (Phase 3 Cohort 1: Critical ITT)
|
NA days
Less than 50% of participants experienced an event response
|
NA days
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA days
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 60Population: Phase 3 Cohort 2 population receiving mechanical ventilation at baseline
Time to Death (All-Cause Mortality)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=16 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Death (Phase 3 Cohort 2)
|
NA days
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA days
Interval 17.0 to
Less than 50% of participants experienced an event response
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 22 and 29Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
Number of Ventilator-Free days up to Day 29 (Phase 3 Cohort 1)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Ventilator-free days up to Day 8
|
0.8 days
Standard Deviation 1.7
|
0.4 days
Standard Deviation 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.6 days
Standard Deviation 1.4
|
—
|
—
|
—
|
|
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Ventilator-free days up to Day 15
|
2.8 days
Standard Deviation 4.4
|
2.2 days
Standard Deviation 3.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2.2 days
Standard Deviation 4.0
|
—
|
—
|
—
|
|
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Ventilator-free days up to Day 22
|
5.5 days
Standard Deviation 7.3
|
4.8 days
Standard Deviation 6.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.3 days
Standard Deviation 6.8
|
—
|
—
|
—
|
|
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical on Mechanical Ventilation at Baseline)
Ventilator-free days up to Day 29
|
8.7 days
Standard Deviation 10.4
|
8.0 days
Standard Deviation 9.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
6.9 days
Standard Deviation 9.9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 22 and 29Population: Phase 3 Cohort 1: Critical ITT population
Number of Ventilator-Free days up to Day 29 (Phase 3 Cohort 1)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT)
Ventilator-free days up to Day 29
|
15.5 days
Standard Deviation 12.4
|
13.9 days
Standard Deviation 12.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
15.3 days
Standard Deviation 12.8
|
—
|
—
|
—
|
|
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT)
Ventilator-free days up to Day 8
|
3.5 days
Standard Deviation 3.3
|
3.2 days
Standard Deviation 3.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.6 days
Standard Deviation 3.3
|
—
|
—
|
—
|
|
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT)
Ventilator-free days up to Day 15
|
7.2 days
Standard Deviation 6.4
|
6.4 days
Standard Deviation 6.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.2 days
Standard Deviation 6.5
|
—
|
—
|
—
|
|
Number of Ventilator-Free Days (Phase 3 Cohort 1: Critical ITT)
Ventilator-free days up to Day 22
|
11.3 days
Standard Deviation 9.4
|
9.9 days
Standard Deviation 9.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11.1 days
Standard Deviation 9.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 22 and 29Population: Phase 3 Cohort 1: Critical population receiving mechanical ventilation at baseline
Number of days of hospitalization among survivors (Phase 3 Cohort 1)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=104 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=132 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=62 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1)
Hospitalized up to Day 29
|
28.5 days
Standard Deviation 1.4
|
28.2 days
Standard Deviation 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
28.3 days
Standard Deviation 1.8
|
—
|
—
|
—
|
|
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1)
Hospitalized up to Day 8
|
7.8 days
Standard Deviation 0.6
|
8.0 days
Standard Deviation 0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.7 days
Standard Deviation 0.9
|
—
|
—
|
—
|
|
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1)
Hospitalized up to Day 15
|
14.4 days
Standard Deviation 1.5
|
14.5 days
Standard Deviation 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.5 days
Standard Deviation 1.5
|
—
|
—
|
—
|
|
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1)
Hospitalized up to Day 22
|
21.6 days
Standard Deviation 1.3
|
21.1 days
Standard Deviation 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20.7 days
Standard Deviation 2.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 8, 15, 22 and 29Population: Phase 3 Cohort 1: Critical ITT population participants with a hospital discharge date on or before Day 29
Number of days of hospitalization among survivors (Phase 3 Cohort 1: Critical ITT population)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=172 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=224 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=111 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT)
Hospitalized up to Day 8
|
7.4 days
Standard Deviation 1.3
|
7.6 days
Standard Deviation 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
7.5 days
Standard Deviation 1.2
|
—
|
—
|
—
|
|
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT)
Hospitalized up to Day 15
|
13.8 days
Standard Deviation 1.9
|
13.8 days
Standard Deviation 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.7 days
Standard Deviation 2.0
|
—
|
—
|
—
|
|
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT)
Hospitalized up to Day 22
|
21.1 days
Standard Deviation 1.8
|
21.2 days
Standard Deviation 1.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
20.8 days
Standard Deviation 2.0
|
—
|
—
|
—
|
|
Number of Days of Hospitalization Among Survivors (Phase 3 Cohort 1: Critical ITT)
Hospitalized up to Day 29
|
28.2 days
Standard Deviation 1.8
|
28.1 days
Standard Deviation 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
28.4 days
Standard Deviation 1.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to day 60Population: Safety population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=170 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=8 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=12 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Serious Adverse Event
|
90 Participants
|
84 Participants
|
89 Participants
|
119 Participants
|
183 Participants
|
11 Participants
|
23 Participants
|
30 Participants
|
27 Participants
|
67 Participants
|
58 Participants
|
3 Participants
|
6 Participants
|
9 Participants
|
10 Participants
|
39 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to day 60Population: Safety population
Grade 4 Neutropenia defined as Absolute Neutrophil Count (ANC) of less than 500 per cubic millimeter(mm3)
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=170 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=8 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=12 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 4 Neutropenia (ANC <500/mm3)
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to day 60Population: Safety population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=170 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=8 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=12 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Severe or Life-threatening Bacterial, Invasive Fungal, or Opportunistic Infection
|
17 Participants
|
25 Participants
|
36 Participants
|
53 Participants
|
72 Participants
|
2 Participants
|
2 Participants
|
10 Participants
|
16 Participants
|
30 Participants
|
28 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
14 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to day 60Population: Safety population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=170 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=8 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=12 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 4 Neutropenia and Concurrent Invasive Infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to day 60Population: Safety population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=170 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=8 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=12 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade >=2 Infusion Related Reactions
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to day 60Population: Safety population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=170 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=8 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=12 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade >=2 Hypersensitivity Reactions
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to day 60Population: Safety population
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=170 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=8 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=12 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Gastrointestinal Perforation
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 2 population. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Leukocyte Values Across Study Days (Phase 2)
Day 1
|
9.41 10^9 cells/liter(L)
Standard Deviation 4.68
|
10.28 10^9 cells/liter(L)
Standard Deviation 6.47
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8.95 10^9 cells/liter(L)
Standard Deviation 3.73
|
—
|
—
|
—
|
|
Mean Observed Leukocyte Values Across Study Days (Phase 2)
Day 4
|
9.00 10^9 cells/liter(L)
Standard Deviation 6.61
|
9.47 10^9 cells/liter(L)
Standard Deviation 6.91
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
10.75 10^9 cells/liter(L)
Standard Deviation 5.54
|
—
|
—
|
—
|
|
Mean Observed Leukocyte Values Across Study Days (Phase 2)
Day 15
|
13.10 10^9 cells/liter(L)
Standard Deviation 7.17
|
12.10 10^9 cells/liter(L)
Standard Deviation 7.78
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.44 10^9 cells/liter(L)
Standard Deviation 5.94
|
—
|
—
|
—
|
|
Mean Observed Leukocyte Values Across Study Days (Phase 2)
Day 29
|
11.20 10^9 cells/liter(L)
Standard Deviation 5.81
|
12.48 10^9 cells/liter(L)
Standard Deviation 6.90
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.06 10^9 cells/liter(L)
Standard Deviation 6.73
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size.
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=8 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=12 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=15 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Leukocyte Values Across Study Days (Phase 3)
Day 1 (Baseline)
|
10.51 10^9 cells/liter(L)
Standard Deviation 4.83
|
10.52 10^9 cells/liter(L)
Standard Deviation 4.442
|
7.83 10^9 cells/liter(L)
Standard Deviation 2.97
|
8.16 10^9 cells/liter(L)
Standard Deviation 3.42
|
8.38 10^9 cells/liter(L)
Standard Deviation 4.06
|
12.01 10^9 cells/liter(L)
Standard Deviation 5.57
|
12.98 10^9 cells/liter(L)
Standard Deviation 5.72
|
12.35 10^9 cells/liter(L)
Standard Deviation 5.78
|
14.26 10^9 cells/liter(L)
Standard Deviation 9.99
|
9.13 10^9 cells/liter(L)
Standard Deviation 5.112
|
7.20 10^9 cells/liter(L)
Standard Deviation 5.28
|
11.52 10^9 cells/liter(L)
Standard Deviation 3.55
|
12.13 10^9 cells/liter(L)
Standard Deviation 5.27
|
8.80 10^9 cells/liter(L)
Standard Deviation 2.14
|
4.80 10^9 cells/liter(L)
Standard Deviation 1.84
|
10.18 10^9 cells/liter(L)
Standard Deviation 4.57
|
—
|
—
|
—
|
|
Mean Observed Leukocyte Values Across Study Days (Phase 3)
Day 4
|
9.47 10^9 cells/liter(L)
Standard Deviation 5.77
|
9.19 10^9 cells/liter(L)
Standard Deviation 5.82
|
7.93 10^9 cells/liter(L)
Standard Deviation 2.87
|
6.76 10^9 cells/liter(L)
Standard Deviation 3.92
|
6.89 10^9 cells/liter(L)
Standard Deviation 5.10
|
13.53 10^9 cells/liter(L)
Standard Deviation 7.44
|
11.62 10^9 cells/liter(L)
Standard Deviation 7.05
|
11.25 10^9 cells/liter(L)
Standard Deviation 8.42
|
13.48 10^9 cells/liter(L)
Standard Deviation 10.88
|
6.44 10^9 cells/liter(L)
Standard Deviation 2.68
|
6.50 10^9 cells/liter(L)
Standard Deviation 6.36
|
12.15 10^9 cells/liter(L)
Standard Deviation 4.87
|
8.30 10^9 cells/liter(L)
Standard Deviation 3.87
|
9.96 10^9 cells/liter(L)
Standard Deviation 2.92
|
4.70 10^9 cells/liter(L)
Standard Deviation 3.54
|
12.11 10^9 cells/liter(L)
Standard Deviation 5.49
|
—
|
—
|
—
|
|
Mean Observed Leukocyte Values Across Study Days (Phase 3)
Day 15
|
11.26 10^9 cells/liter(L)
Standard Deviation 6.79
|
10.47 10^9 cells/liter(L)
Standard Deviation 6.28
|
10.58 10^9 cells/liter(L)
Standard Deviation 5.86
|
9.68 10^9 cells/liter(L)
Standard Deviation 4.88
|
11.18 10^9 cells/liter(L)
Standard Deviation 10.52
|
13.97 10^9 cells/liter(L)
Standard Deviation 5.57
|
12.73 10^9 cells/liter(L)
Standard Deviation 7.25
|
11.90 10^9 cells/liter(L)
Standard Deviation 8.88
|
22.45 10^9 cells/liter(L)
Standard Deviation 17.05
|
8.12 10^9 cells/liter(L)
Standard Deviation 2.75
|
12.84 10^9 cells/liter(L)
Standard Deviation 7.21
|
11.70 10^9 cells/liter(L)
Standard Deviation 4.81
|
10.68 10^9 cells/liter(L)
Standard Deviation 10.76
|
14.45 10^9 cells/liter(L)
Standard Deviation 8.12
|
16.40 10^9 cells/liter(L)
Standard Deviation 1.84
|
12.03 10^9 cells/liter(L)
Standard Deviation 4.68
|
—
|
—
|
—
|
|
Mean Observed Leukocyte Values Across Study Days (Phase 3)
Day 29
|
12.17 10^9 cells/liter(L)
Standard Deviation 7.45
|
31.35 10^9 cells/liter(L)
Standard Deviation 194.41
|
7.81 10^9 cells/liter(L)
Standard Deviation 2.66
|
11.56 10^9 cells/liter(L)
Standard Deviation 6.67
|
11.72 10^9 cells/liter(L)
Standard Deviation 6.28
|
10.22 10^9 cells/liter(L)
Standard Deviation 3.62
|
11.15 10^9 cells/liter(L)
Standard Deviation 6.84
|
10.50 10^9 cells/liter(L)
Standard Deviation 6.44
|
18.30 10^9 cells/liter(L)
Standard Deviation 0
|
9.52 10^9 cells/liter(L)
Standard Deviation 5.47
|
14.10 10^9 cells/liter(L)
Standard Deviation 11.02
|
11.22 10^9 cells/liter(L)
Standard Deviation 8.67
|
7.43 10^9 cells/liter(L)
Standard Deviation 2.57
|
28.44 10^9 cells/liter(L)
Standard Deviation 22.96
|
7.50 10^9 cells/liter(L)
Standard Deviation 5.09
|
11.90 10^9 cells/liter(L)
Standard Deviation 6.00
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 2 population. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Hemoglobin Values Across Study Days (Phase 2)
Day 1 (Baseline)
|
122.19 grams/Liter (g/L)
Standard Deviation 19.75
|
122.75 grams/Liter (g/L)
Standard Deviation 20.27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
122.53 grams/Liter (g/L)
Standard Deviation 20.65
|
—
|
—
|
—
|
|
Mean Observed Hemoglobin Values Across Study Days (Phase 2)
Day 4
|
122.79 grams/Liter (g/L)
Standard Deviation 20.44
|
122.61 grams/Liter (g/L)
Standard Deviation 20.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
120.30 grams/Liter (g/L)
Standard Deviation 28.23
|
—
|
—
|
—
|
|
Mean Observed Hemoglobin Values Across Study Days (Phase 2)
Day 15
|
104.11 grams/Liter (g/L)
Standard Deviation 21.88
|
105.85 grams/Liter (g/L)
Standard Deviation 22.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100.04 grams/Liter (g/L)
Standard Deviation 22.39
|
—
|
—
|
—
|
|
Mean Observed Hemoglobin Values Across Study Days (Phase 2)
Day 29
|
96.00 grams/Liter (g/L)
Standard Deviation 21.36
|
98.20 grams/Liter (g/L)
Standard Deviation 19.20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
90.48 grams/Liter (g/L)
Standard Deviation 15.30
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=8 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=12 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=15 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Hemoglobin Values Across Study Days (Phase 3)
Day 1 (Baseline)
|
121.25 grams/Liter (g/L)
Standard Deviation 20.39
|
121.06 grams/Liter (g/L)
Standard Deviation 19.97
|
127.64 grams/Liter (g/L)
Standard Deviation 15.27
|
124.18 grams/Liter (g/L)
Standard Deviation 20.59
|
124.76 grams/Liter (g/L)
Standard Deviation 20.64
|
114.59 grams/Liter (g/L)
Standard Deviation 19.03
|
110.40 grams/Liter (g/L)
Standard Deviation 22.34
|
104.19 grams/Liter (g/L)
Standard Deviation 19.40
|
121.88 grams/Liter (g/L)
Standard Deviation 24.00
|
120.55 grams/Liter (g/L)
Standard Deviation 18.93
|
99.00 grams/Liter (g/L)
Standard Deviation 22.83
|
111.20 grams/Liter (g/L)
Standard Deviation 19.01
|
115.75 grams/Liter (g/L)
Standard Deviation 21.51
|
122.00 grams/Liter (g/L)
Standard Deviation 17.16
|
111.50 grams/Liter (g/L)
Standard Deviation 33.23
|
117.70 grams/Liter (g/L)
Standard Deviation 19.85
|
—
|
—
|
—
|
|
Mean Observed Hemoglobin Values Across Study Days (Phase 3)
Day 4
|
121.03 grams/Liter (g/L)
Standard Deviation 20.83
|
120.57 grams/Liter (g/L)
Standard Deviation 21.82
|
123.58 grams/Liter (g/L)
Standard Deviation 16.89
|
125.70 grams/Liter (g/L)
Standard Deviation 20.59
|
125.61 grams/Liter (g/L)
Standard Deviation 20.74
|
101.36 grams/Liter (g/L)
Standard Deviation 16.90
|
106.55 grams/Liter (g/L)
Standard Deviation 21.22
|
102.46 grams/Liter (g/L)
Standard Deviation 20.43
|
114.13 grams/Liter (g/L)
Standard Deviation 15.57
|
118.25 grams/Liter (g/L)
Standard Deviation 21.64
|
97.13 grams/Liter (g/L)
Standard Deviation 22.68
|
103.73 grams/Liter (g/L)
Standard Deviation 19.49
|
114.56 grams/Liter (g/L)
Standard Deviation 17.00
|
115.33 grams/Liter (g/L)
Standard Deviation 16.15
|
113.50 grams/Liter (g/L)
Standard Deviation 38.89
|
112.90 grams/Liter (g/L)
Standard Deviation 20.72
|
—
|
—
|
—
|
|
Mean Observed Hemoglobin Values Across Study Days (Phase 3)
Day 15
|
104.70 grams/Liter (g/L)
Standard Deviation 22.93
|
107.87 grams/Liter (g/L)
Standard Deviation 23.48
|
112.15 grams/Liter (g/L)
Standard Deviation 21.36
|
106.27 grams/Liter (g/L)
Standard Deviation 20.25
|
113.43 grams/Liter (g/L)
Standard Deviation 27.11
|
91.16 grams/Liter (g/L)
Standard Deviation 15.85
|
95.21 grams/Liter (g/L)
Standard Deviation 18.30
|
90.88 grams/Liter (g/L)
Standard Deviation 18.37
|
106.75 grams/Liter (g/L)
Standard Deviation 28.94
|
111.00 grams/Liter (g/L)
Standard Deviation 21.87
|
91.86 grams/Liter (g/L)
Standard Deviation 19.15
|
92.85 grams/Liter (g/L)
Standard Deviation 16.80
|
109.43 grams/Liter (g/L)
Standard Deviation 15.54
|
103.40 grams/Liter (g/L)
Standard Deviation 20.88
|
101.50 grams/Liter (g/L)
Standard Deviation 14.85
|
99.66 grams/Liter (g/L)
Standard Deviation 20.00
|
—
|
—
|
—
|
|
Mean Observed Hemoglobin Values Across Study Days (Phase 3)
Day 29
|
91.50 grams/Liter (g/L)
Standard Deviation 18.08
|
96.28 grams/Liter (g/L)
Standard Deviation 19.50
|
86.67 grams/Liter (g/L)
Standard Deviation 17.67
|
99.58 grams/Liter (g/L)
Standard Deviation 22.48
|
88.92 grams/Liter (g/L)
Standard Deviation 22.72
|
85.23 grams/Liter (g/L)
Standard Deviation 10.88
|
88.74 grams/Liter (g/L)
Standard Deviation 13.27
|
88.44 grams/Liter (g/L)
Standard Deviation 15.13
|
135.00 grams/Liter (g/L)
Standard Deviation 0
|
96.00 grams/Liter (g/L)
Standard Deviation 11.27
|
85.20 grams/Liter (g/L)
Standard Deviation 13.68
|
99.40 grams/Liter (g/L)
Standard Deviation 23.03
|
106.29 grams/Liter (g/L)
Standard Deviation 12.59
|
98.50 grams/Liter (g/L)
Standard Deviation 38.89
|
82.50 grams/Liter (g/L)
Standard Deviation 6.36
|
84.31 grams/Liter (g/L)
Standard Deviation 15.05
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 2 population. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Platelet Count Across Study Days (Phase 2)
Day 1 (Baseline)
|
249.40 10^9 platelets/liter(L)
Standard Deviation 100.55
|
261.50 10^9 platelets/liter(L)
Standard Deviation 94.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
241.03 10^9 platelets/liter(L)
Standard Deviation 102.22
|
—
|
—
|
—
|
|
Mean Observed Platelet Count Across Study Days (Phase 2)
Day 4
|
304.94 10^9 platelets/liter(L)
Standard Deviation 117.17
|
319.89 10^9 platelets/liter(L)
Standard Deviation 116.80
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
314.86 10^9 platelets/liter(L)
Standard Deviation 129.80
|
—
|
—
|
—
|
|
Mean Observed Platelet Count Across Study Days (Phase 2)
Day 15
|
264.03 10^9 platelets/liter(L)
Standard Deviation 116.22
|
257.88 10^9 platelets/liter(L)
Standard Deviation 118.01
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
351.89 10^9 platelets/liter(L)
Standard Deviation 155.08
|
—
|
—
|
—
|
|
Mean Observed Platelet Count Across Study Days (Phase 2)
Day 29
|
306.87 10^9 platelets/liter(L)
Standard Deviation 119.10
|
312.14 10^9 platelets/liter(L)
Standard Deviation 147.07
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
313.12 10^9 platelets/liter(L)
Standard Deviation 148.66
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=8 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=12 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=15 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Platelet Count Across Study Days (Phase 3)
Day 1 (Baseline)
|
278.60 10^9 platelets/liter(L)
Standard Deviation 112.15
|
278.40 10^9 platelets/liter(L)
Standard Deviation 120.16
|
251.03 10^9 platelets/liter(L)
Standard Deviation 109.74
|
271.70 10^9 platelets/liter(L)
Standard Deviation 109.63
|
259.06 10^9 platelets/liter(L)
Standard Deviation 115.47
|
244.11 10^9 platelets/liter(L)
Standard Deviation 103.10
|
251.85 10^9 platelets/liter(L)
Standard Deviation 105.45
|
258.37 10^9 platelets/liter(L)
Standard Deviation 100.32
|
233.00 10^9 platelets/liter(L)
Standard Deviation 74.04
|
221.64 10^9 platelets/liter(L)
Standard Deviation 84.86
|
190.33 10^9 platelets/liter(L)
Standard Deviation 77.23
|
228.40 10^9 platelets/liter(L)
Standard Deviation 121.12
|
278.31 10^9 platelets/liter(L)
Standard Deviation 130.65
|
298.50 10^9 platelets/liter(L)
Standard Deviation 114.86
|
197.00 10^9 platelets/liter(L)
Standard Deviation 22.63
|
285.56 10^9 platelets/liter(L)
Standard Deviation 120.77
|
—
|
—
|
—
|
|
Mean Observed Platelet Count Across Study Days (Phase 3)
Day 4
|
318.16 10^9 platelets/liter(L)
Standard Deviation 129.76
|
311.42 10^9 platelets/liter(L)
Standard Deviation 136.44
|
324.57 10^9 platelets/liter(L)
Standard Deviation 154.49
|
348.96 10^9 platelets/liter(L)
Standard Deviation 135.13
|
330.84 10^9 platelets/liter(L)
Standard Deviation 154.22
|
276.70 10^9 platelets/liter(L)
Standard Deviation 111.39
|
275.84 10^9 platelets/liter(L)
Standard Deviation 116.70
|
268.18 10^9 platelets/liter(L)
Standard Deviation 116.49
|
244.88 10^9 platelets/liter(L)
Standard Deviation 73.27
|
261.00 10^9 platelets/liter(L)
Standard Deviation 109.90
|
225.47 10^9 platelets/liter(L)
Standard Deviation 75.84
|
267.80 10^9 platelets/liter(L)
Standard Deviation 132.29
|
318.25 10^9 platelets/liter(L)
Standard Deviation 134.09
|
421.17 10^9 platelets/liter(L)
Standard Deviation 135.03
|
294.00 10^9 platelets/liter(L)
Standard Deviation 127.28
|
328.20 10^9 platelets/liter(L)
Standard Deviation 137.22
|
—
|
—
|
—
|
|
Mean Observed Platelet Count Across Study Days (Phase 3)
Day 15
|
230.44 10^9 platelets/liter(L)
Standard Deviation 100.71
|
222.62 10^9 platelets/liter(L)
Standard Deviation 100.21
|
271.71 10^9 platelets/liter(L)
Standard Deviation 124.32
|
242.40 10^9 platelets/liter(L)
Standard Deviation 82.25
|
223.14 10^9 platelets/liter(L)
Standard Deviation 102.57
|
312.81 10^9 platelets/liter(L)
Standard Deviation 155.88
|
232.97 10^9 platelets/liter(L)
Standard Deviation 115.44
|
226.89 10^9 platelets/liter(L)
Standard Deviation 110.91
|
219.25 10^9 platelets/liter(L)
Standard Deviation 77.89
|
203.63 10^9 platelets/liter(L)
Standard Deviation 47.37
|
133.14 10^9 platelets/liter(L)
Standard Deviation 59.74
|
275.69 10^9 platelets/liter(L)
Standard Deviation 150.11
|
209.00 10^9 platelets/liter(L)
Standard Deviation 92.41
|
306.60 10^9 platelets/liter(L)
Standard Deviation 108.91
|
259.00 10^9 platelets/liter(L)
Standard Deviation 39.60
|
315.38 10^9 platelets/liter(L)
Standard Deviation 143.62
|
—
|
—
|
—
|
|
Mean Observed Platelet Count Across Study Days (Phase 3)
Day 29
|
270.88 10^9 platelets/liter(L)
Standard Deviation 102.72
|
248.60 10^9 platelets/liter(L)
Standard Deviation 139.26
|
264.67 10^9 platelets/liter(L)
Standard Deviation 147.97
|
238.67 10^9 platelets/liter(L)
Standard Deviation 125.15
|
182.58 10^9 platelets/liter(L)
Standard Deviation 107.29
|
332.73 10^9 platelets/liter(L)
Standard Deviation 156.61
|
310.52 10^9 platelets/liter(L)
Standard Deviation 155.05
|
279.31 10^9 platelets/liter(L)
Standard Deviation 124.43
|
267.00 10^9 platelets/liter(L)
Standard Deviation 0
|
281.00 10^9 platelets/liter(L)
Standard Deviation 130.09
|
181.25 10^9 platelets/liter(L)
Standard Deviation 53.01
|
265.00 10^9 platelets/liter(L)
Standard Deviation 70.67
|
235.71 10^9 platelets/liter(L)
Standard Deviation 100.19
|
272.00 10^9 platelets/liter(L)
Standard Deviation 26.87
|
373.00 10^9 platelets/liter(L)
Standard Deviation 367.70
|
284.02 10^9 platelets/liter(L)
Standard Deviation 143.38
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 2 Population. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Total Bilirubin Values Across Study Days (Phase 2)
Day 1 (Baseline)
|
11.96 micromole/liter (umol/L)
Standard Deviation 13.59
|
12.24 micromole/liter (umol/L)
Standard Deviation 15.77
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.07 micromole/liter (umol/L)
Standard Deviation 14.20
|
—
|
—
|
—
|
|
Mean Observed Total Bilirubin Values Across Study Days (Phase 2)
Day 4
|
11.87 micromole/liter (umol/L)
Standard Deviation 17.12
|
9.89 micromole/liter (umol/L)
Standard Deviation 11.10
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
12.44 micromole/liter (umol/L)
Standard Deviation 10.90
|
—
|
—
|
—
|
|
Mean Observed Total Bilirubin Values Across Study Days (Phase 2)
Day 15
|
12.43 micromole/liter (umol/L)
Standard Deviation 8.69
|
14.16 micromole/liter (umol/L)
Standard Deviation 21.94
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13.75 micromole/liter (umol/L)
Standard Deviation 17.63
|
—
|
—
|
—
|
|
Mean Observed Total Bilirubin Values Across Study Days (Phase 2)
Day 29
|
7.87 micromole/liter (umol/L)
Standard Deviation 3.44
|
11.40 micromole/liter (umol/L)
Standard Deviation 12.23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
14.00 micromole/liter (umol/L)
Standard Deviation 19.84
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=8 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=12 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=15 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Total Bilirubin Across Study Days (Phase 3)
Day 1 (Baseline)
|
12.02 umol/L
Standard Deviation 7.82
|
12.99 umol/L
Standard Deviation 14.20
|
9.09 umol/L
Standard Deviation 4.17
|
9.93 umol/L
Standard Deviation 5.27
|
10.12 umol/L
Standard Deviation 5.95
|
10.94 umol/L
Standard Deviation 8.57
|
16.89 umol/L
Standard Deviation 21.77
|
16.56 umol/L
Standard Deviation 13.46
|
6.27 umol/L
Standard Deviation 2.57
|
10.10 umol/L
Standard Deviation 9.90
|
7.30 umol/L
Standard Deviation 4.77
|
10.79 umol/L
Standard Deviation 7.47
|
9.92 umol/L
Standard Deviation 5.93
|
9.98 umol/L
Standard Deviation 1.68
|
9.41 umol/L
Standard Deviation 1.21
|
11.79 umol/L
Standard Deviation 7.66
|
—
|
—
|
—
|
|
Mean Observed Total Bilirubin Across Study Days (Phase 3)
Day 4
|
10.10 umol/L
Standard Deviation 6.39
|
10.21 umol/L
Standard Deviation 8.61
|
9.53 umol/L
Standard Deviation 4.67
|
8.45 umol/L
Standard Deviation 5.43
|
8.38 umol/L
Standard Deviation 4.16
|
14.57 umol/L
Standard Deviation 14.93
|
10.94 umol/L
Standard Deviation 10.45
|
13.98 umol/L
Standard Deviation 11.00
|
7.98 umol/L
Standard Deviation 6.18
|
10.26 umol/L
Standard Deviation 8.12
|
6.96 umol/L
Standard Deviation 3.11
|
12.43 umol/L
Standard Deviation 5.19
|
7.70 umol/L
Standard Deviation 5.15
|
11.40 umol/L
Standard Deviation 4.55
|
9.41 umol/L
Standard Deviation 3.63
|
13.11 umol/L
Standard Deviation 13.11
|
—
|
—
|
—
|
|
Mean Observed Total Bilirubin Across Study Days (Phase 3)
Day 15
|
11.66 umol/L
Standard Deviation 8.09
|
15.60 umol/L
Standard Deviation 48.78
|
8.66 umol/L
Standard Deviation 2.54
|
11.07 umol/L
Standard Deviation 7.15
|
19.37 umol/L
Standard Deviation 47.14
|
13.20 umol/L
Standard Deviation 11.02
|
10.69 umol/L
Standard Deviation 7.93
|
14.26 umol/L
Standard Deviation 18.85
|
19.24 umol/L
Standard Deviation 10.76
|
16.37 umol/L
Standard Deviation 24.60
|
8.55 umol/L
Standard Deviation 2.61
|
23.09 umol/L
Standard Deviation 45.49
|
10.97 umol/L
Standard Deviation 3.53
|
10.26 umol/L
Standard Deviation 4.52
|
11.97 umol/L
Standard Deviation 2.42
|
16.47 umol/L
Standard Deviation 37.13
|
—
|
—
|
—
|
|
Mean Observed Total Bilirubin Across Study Days (Phase 3)
Day 29
|
11.74 umol/L
Standard Deviation 13.86
|
19.24 umol/L
Standard Deviation 38.66
|
9.69 umol/L
Standard Deviation 0.99
|
25.48 umol/L
Standard Deviation 38.28
|
31.19 umol/L
Standard Deviation 71.38
|
9.69 umol/L
Standard Deviation 9.13
|
9.44 umol/L
Standard Deviation 9.44
|
10.54 umol/L
Standard Deviation 8.19
|
13.68 umol/L
Standard Deviation 0
|
3.42 umol/L
Standard Deviation 0
|
8.89 umol/L
Standard Deviation 3.71
|
4.27 umol/L
Standard Deviation 1.21
|
6.56 umol/L
Standard Deviation 2.52
|
13.68 umol/L
Standard Deviation 14.51
|
7.70 umol/L
Standard Deviation 3.63
|
11.66 umol/L
Standard Deviation 11.00
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 2 Population. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2)
Day 1 (Baseline)
|
57.88 International Units/Liter (IU/L)
Standard Deviation 33.35
|
60.39 International Units/Liter (IU/L)
Standard Deviation 36.85
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
58.58 International Units/Liter (IU/L)
Standard Deviation 32.40
|
—
|
—
|
—
|
|
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2)
Day 4
|
90.01 International Units/Liter (IU/L)
Standard Deviation 127.42
|
78.34 International Units/Liter (IU/L)
Standard Deviation 63.75
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
62.52 International Units/Liter (IU/L)
Standard Deviation 61.41
|
—
|
—
|
—
|
|
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2)
Day 15
|
188.65 International Units/Liter (IU/L)
Standard Deviation 941.96
|
88.96 International Units/Liter (IU/L)
Standard Deviation 329.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
42.12 International Units/Liter (IU/L)
Standard Deviation 25.17
|
—
|
—
|
—
|
|
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 2)
Day 29
|
40.69 International Units/Liter (IU/L)
Standard Deviation 35.70
|
100.05 International Units/Liter (IU/L)
Standard Deviation 337.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
76.00 International Units/Liter (IU/L)
Standard Deviation 82.78
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=8 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=12 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=15 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3)
Day 4
|
69.30 IU/L
Standard Deviation 65.10
|
78.29 IU/L
Standard Deviation 108.57
|
52.79 IU/L
Standard Deviation 39.90
|
66.47 IU/L
Standard Deviation 63.95
|
76.77 IU/L
Standard Deviation 178.97
|
65.39 IU/L
Standard Deviation 52.27
|
94.76 IU/L
Standard Deviation 136.93
|
124.83 IU/L
Standard Deviation 270.78
|
58.00 IU/L
Standard Deviation 69.65
|
51.33 IU/L
Standard Deviation 33.72
|
52.93 IU/L
Standard Deviation 48.68
|
76.73 IU/L
Standard Deviation 35.24
|
75.88 IU/L
Standard Deviation 51.15
|
74.50 IU/L
Standard Deviation 65.31
|
32.50 IU/L
Standard Deviation 19.09
|
60.21 IU/L
Standard Deviation 74.93
|
—
|
—
|
—
|
|
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3)
Day 1 (Baseline)
|
54.73 IU/L
Standard Deviation 35.99
|
60.61 IU/L
Standard Deviation 39.15
|
51.54 IU/L
Standard Deviation 28.35
|
58.58 IU/L
Standard Deviation 45.19
|
47.80 IU/L
Standard Deviation 29.38
|
61.13 IU/L
Standard Deviation 38.23
|
77.66 IU/L
Standard Deviation 163.34
|
57.68 IU/L
Standard Deviation 36.02
|
47.00 IU/L
Standard Deviation 37.44
|
47.36 IU/L
Standard Deviation 24.52
|
35.47 IU/L
Standard Deviation 22.96
|
58.77 IU/L
Standard Deviation 42.03
|
58.33 IU/L
Standard Deviation 27.48
|
114.00 IU/L
Standard Deviation 134.17
|
36.50 IU/L
Standard Deviation 3.54
|
58.54 IU/L
Standard Deviation 33.67
|
—
|
—
|
—
|
|
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3)
Day 15
|
72.27 IU/L
Standard Deviation 232.21
|
75.08 IU/L
Standard Deviation 162.60
|
38.73 IU/L
Standard Deviation 20.81
|
73.42 IU/L
Standard Deviation 152.57
|
126.70 IU/L
Standard Deviation 312.36
|
50.00 IU/L
Standard Deviation 37.36
|
49.89 IU/L
Standard Deviation 46.50
|
98.84 IU/L
Standard Deviation 276.99
|
128.25 IU/L
Standard Deviation 180.12
|
45.29 IU/L
Standard Deviation 26.30
|
52.29 IU/L
Standard Deviation 43.10
|
33.17 IU/L
Standard Deviation 9.68
|
64.08 IU/L
Standard Deviation 58.97
|
40.00 IU/L
Standard Deviation 41.87
|
15.00 IU/L
Standard Deviation 4.24
|
62.95 IU/L
Standard Deviation 131.49
|
—
|
—
|
—
|
|
Mean Observed Aspartate Aminotransferase Values Across Study Days (Phase 3)
Day 29
|
163.83 IU/L
Standard Deviation 817.08
|
363.69 IU/L
Standard Deviation 2565.77
|
80.33 IU/L
Standard Deviation 65.90
|
347.60 IU/L
Standard Deviation 982.89
|
72.17 IU/L
Standard Deviation 86.39
|
35.24 IU/L
Standard Deviation 21.51
|
40.07 IU/L
Standard Deviation 25.67
|
38.19 IU/L
Standard Deviation 29.82
|
25.00 IU/L
Standard Deviation 0
|
20.00 IU/L
Standard Deviation 0
|
31.20 IU/L
Standard Deviation 16.69
|
25.50 IU/L
Standard Deviation 13.44
|
46.67 IU/L
Standard Deviation 39.87
|
69.00 IU/L
Standard Deviation 57.98
|
46.00 IU/L
Standard Deviation 42.43
|
52.76 IU/L
Standard Deviation 102.66
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 2 Population. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2)
Day 1 (Baseline)
|
50.25 International Units/Liter (IU/L)
Standard Deviation 36.69
|
48.25 International Units/Liter (IU/L)
Standard Deviation 30.38
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
47.93 International Units/Liter (IU/L)
Standard Deviation 34.75
|
—
|
—
|
—
|
|
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2)
Day 4
|
86.08 International Units/Liter (IU/L)
Standard Deviation 148.46
|
74.20 International Units/Liter (IU/L)
Standard Deviation 78.45
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
54.34 International Units/Liter (IU/L)
Standard Deviation 42.15
|
—
|
—
|
—
|
|
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2)
Day 15
|
106.17 International Units/Liter (IU/L)
Standard Deviation 282.61
|
121.58 International Units/Liter (IU/L)
Standard Deviation 507.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
55.00 International Units/Liter (IU/L)
Standard Deviation 37.75
|
—
|
—
|
—
|
|
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 2)
Day 29
|
58.63 International Units/Liter (IU/L)
Standard Deviation 48.92
|
64.82 International Units/Liter (IU/L)
Standard Deviation 78.90
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
94.30 International Units/Liter (IU/L)
Standard Deviation 112.36
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=8 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=12 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=15 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3)
Day 1 (Baseline)
|
51.08 International Units/Liter (IU/L)
Standard Deviation 35.87
|
52.15 International Units/Liter (IU/L)
Standard Deviation 36.66
|
46.69 International Units/Liter (IU/L)
Standard Deviation 34.09
|
54.22 International Units/Liter (IU/L)
Standard Deviation 42.27
|
49.43 International Units/Liter (IU/L)
Standard Deviation 39.98
|
45.00 International Units/Liter (IU/L)
Standard Deviation 35.07
|
59.13 International Units/Liter (IU/L)
Standard Deviation 96.74
|
41.75 International Units/Liter (IU/L)
Standard Deviation 29.42
|
33.50 International Units/Liter (IU/L)
Standard Deviation 18.45
|
43.00 International Units/Liter (IU/L)
Standard Deviation 31.81
|
22.27 International Units/Liter (IU/L)
Standard Deviation 25.57
|
46.77 International Units/Liter (IU/L)
Standard Deviation 31.49
|
45.33 International Units/Liter (IU/L)
Standard Deviation 40.77
|
103.33 International Units/Liter (IU/L)
Standard Deviation 153.15
|
33.50 International Units/Liter (IU/L)
Standard Deviation 30.41
|
51.69 International Units/Liter (IU/L)
Standard Deviation 37.36
|
—
|
—
|
—
|
|
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3)
Day 4
|
72.32 International Units/Liter (IU/L)
Standard Deviation 60.25
|
74.62 International Units/Liter (IU/L)
Standard Deviation 77.09
|
59.38 International Units/Liter (IU/L)
Standard Deviation 51.04
|
68.69 International Units/Liter (IU/L)
Standard Deviation 51.45
|
86.13 International Units/Liter (IU/L)
Standard Deviation 146.92
|
52.22 International Units/Liter (IU/L)
Standard Deviation 52.86
|
69.75 International Units/Liter (IU/L)
Standard Deviation 102.66
|
84.68 International Units/Liter (IU/L)
Standard Deviation 152.72
|
40.86 International Units/Liter (IU/L)
Standard Deviation 26.62
|
45.17 International Units/Liter (IU/L)
Standard Deviation 23.35
|
38.50 International Units/Liter (IU/L)
Standard Deviation 45.66
|
62.27 International Units/Liter (IU/L)
Standard Deviation 33.29
|
53.06 International Units/Liter (IU/L)
Standard Deviation 44.57
|
103.67 International Units/Liter (IU/L)
Standard Deviation 174.35
|
32.00 International Units/Liter (IU/L)
Standard Deviation 28.28
|
73.45 International Units/Liter (IU/L)
Standard Deviation 139.06
|
—
|
—
|
—
|
|
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3)
Day 15
|
79.98 International Units/Liter (IU/L)
Standard Deviation 131.21
|
93.82 International Units/Liter (IU/L)
Standard Deviation 155.98
|
52.60 International Units/Liter (IU/L)
Standard Deviation 48.06
|
97.73 International Units/Liter (IU/L)
Standard Deviation 205.87
|
101.00 International Units/Liter (IU/L)
Standard Deviation 156.42
|
62.11 International Units/Liter (IU/L)
Standard Deviation 42.15
|
64.80 International Units/Liter (IU/L)
Standard Deviation 68.11
|
98.31 International Units/Liter (IU/L)
Standard Deviation 163.08
|
257.25 International Units/Liter (IU/L)
Standard Deviation 454.57
|
66.14 International Units/Liter (IU/L)
Standard Deviation 51.89
|
47.57 International Units/Liter (IU/L)
Standard Deviation 53.53
|
45.83 International Units/Liter (IU/L)
Standard Deviation 24.52
|
85.75 International Units/Liter (IU/L)
Standard Deviation 104.56
|
24.33 International Units/Liter (IU/L)
Standard Deviation 7.51
|
14.00 International Units/Liter (IU/L)
Standard Deviation 4.24
|
71.09 International Units/Liter (IU/L)
Standard Deviation 71.11
|
—
|
—
|
—
|
|
Mean Observed Alanine Aminotransferase Values Across Study Days (Phase 3)
Day 29
|
86.04 International Units/Liter (IU/L)
Standard Deviation 155.72
|
155.63 International Units/Liter (IU/L)
Standard Deviation 759.34
|
60.00 International Units/Liter (IU/L)
Standard Deviation 36.37
|
127.30 International Units/Liter (IU/L)
Standard Deviation 173.38
|
88.17 International Units/Liter (IU/L)
Standard Deviation 127.32
|
46.24 International Units/Liter (IU/L)
Standard Deviation 48.87
|
46.85 International Units/Liter (IU/L)
Standard Deviation 28.14
|
48.51 International Units/Liter (IU/L)
Standard Deviation 39.44
|
17.00 International Units/Liter (IU/L)
Standard Deviation 0
|
39.00 International Units/Liter (IU/L)
Standard Deviation 0
|
36.00 International Units/Liter (IU/L)
Standard Deviation 32.99
|
25.50 International Units/Liter (IU/L)
Standard Deviation 0.71
|
58.33 International Units/Liter (IU/L)
Standard Deviation 33.66
|
48.00 International Units/Liter (IU/L)
Standard Deviation 12.73
|
83.50 International Units/Liter (IU/L)
Standard Deviation 85.56
|
66.71 International Units/Liter (IU/L)
Standard Deviation 107.24
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 2 population. Only those participants with data available at the specified time points were analyzed.
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=187 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=180 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=90 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Creatinine Values Across Study Days (Phase 2)
Day 1 (Baseline)
|
137.20 micromole/liter (umol/L)
Standard Deviation 148.58
|
158.18 micromole/liter (umol/L)
Standard Deviation 242.13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
129.81 micromole/liter (umol/L)
Standard Deviation 142.13
|
—
|
—
|
—
|
|
Mean Observed Creatinine Values Across Study Days (Phase 2)
Day 4
|
151.86 micromole/liter (umol/L)
Standard Deviation 163.45
|
164.62 micromole/liter (umol/L)
Standard Deviation 246.69
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
153.12 micromole/liter (umol/L)
Standard Deviation 184.77
|
—
|
—
|
—
|
|
Mean Observed Creatinine Values Across Study Days (Phase 2)
Day 15
|
168.74 micromole/liter (umol/L)
Standard Deviation 201.28
|
155.23 micromole/liter (umol/L)
Standard Deviation 163.50
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
188.56 micromole/liter (umol/L)
Standard Deviation 260.81
|
—
|
—
|
—
|
|
Mean Observed Creatinine Values Across Study Days (Phase 2)
Day 29
|
138.02 micromole/liter (umol/L)
Standard Deviation 121.95
|
118.56 micromole/liter (umol/L)
Standard Deviation 133.25
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
147.52 micromole/liter (umol/L)
Standard Deviation 138.14
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1, 4, 15 and 29Population: Phase 3 population. Only those participants with data available at the specified time points were analyzed. Phase 3 Cohort 3 data was not summarized due to insufficient sample size
Outcome measures
| Measure |
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=70 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=140 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=137 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=46 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200mg IV - MSOD
n=95 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400mg IV - MSOD
n=92 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD)\[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=8 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Immunocompromised
n=12 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Immunocompromised
n=15 Participants
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=15 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 Participants
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 Participants
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 2: Placebo
n=170 Participants
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Observed Creatinine Values Across Study Days (Phase 3)
Day 1 (Baseline)
|
141.97 umol/L
Standard Deviation 187.40
|
121.75 umol/L
Standard Deviation 132.43
|
109.14 umol/L
Standard Deviation 196.52
|
174.92 umol/L
Standard Deviation 802.76
|
111.63 umol/L
Standard Deviation 168.83
|
187.93 umol/L
Standard Deviation 232.11
|
308.63 umol/L
Standard Deviation 308.42
|
280.83 umol/L
Standard Deviation 280.30
|
259.01 umol/L
Standard Deviation 401.63
|
265.36 umol/L
Standard Deviation 396.16
|
401.87 umol/L
Standard Deviation 294.63
|
103.19 umol/L
Standard Deviation 74.60
|
78.79 umol/L
Standard Deviation 30.71
|
108.73 umol/L
Standard Deviation 92.72
|
497.25 umol/L
Standard Deviation 621.96
|
122.64 umol/L
Standard Deviation 145.57
|
—
|
—
|
—
|
|
Mean Observed Creatinine Values Across Study Days (Phase 3)
Day 4
|
129.08 umol/L
Standard Deviation 145.08
|
128.56 umol/L
Standard Deviation 127.48
|
93.23 umol/L
Standard Deviation 151.97
|
101.45 umol/L
Standard Deviation 129.88
|
113.30 umol/L
Standard Deviation 152.19
|
176.80 umol/L
Standard Deviation 160.17
|
314.53 umol/L
Standard Deviation 352.59
|
281.92 umol/L
Standard Deviation 310.48
|
267.96 umol/L
Standard Deviation 479.59
|
205.38 umol/L
Standard Deviation 249.38
|
395.09 umol/L
Standard Deviation 246.34
|
121.40 umol/L
Standard Deviation 84.33
|
99.28 umol/L
Standard Deviation 96.74
|
83.24 umol/L
Standard Deviation 62.60
|
458.80 umol/L
Standard Deviation 576.33
|
133.77 umol/L
Standard Deviation 144.10
|
—
|
—
|
—
|
|
Mean Observed Creatinine Values Across Study Days (Phase 3)
Day 15
|
136.98 umol/L
Standard Deviation 149.03
|
120.96 umol/L
Standard Deviation 134.39
|
151.11 umol/L
Standard Deviation 284.59
|
175.09 umol/L
Standard Deviation 243.54
|
111.99 umol/L
Standard Deviation 97.29
|
160.94 umol/L
Standard Deviation 198.07
|
179.87 umol/L
Standard Deviation 183.06
|
170.10 umol/L
Standard Deviation 198.20
|
142.32 umol/L
Standard Deviation 115.06
|
137.46 umol/L
Standard Deviation 99.29
|
270.39 umol/L
Standard Deviation 176.43
|
116.96 umol/L
Standard Deviation 92.34
|
86.06 umol/L
Standard Deviation 64.78
|
136.49 umol/L
Standard Deviation 110.96
|
311.61 umol/L
Standard Deviation 396.93
|
151.06 umol/L
Standard Deviation 175.53
|
—
|
—
|
—
|
|
Mean Observed Creatinine Values Across Study Days (Phase 3)
Day 29
|
124.97 umol/L
Standard Deviation 124.62
|
100.02 umol/L
Standard Deviation 107.10
|
122.88 umol/L
Standard Deviation 161.56
|
205.17 umol/L
Standard Deviation 269.33
|
143.62 umol/L
Standard Deviation 98.50
|
128.74 umol/L
Standard Deviation 191.15
|
125.21 umol/L
Standard Deviation 128.22
|
197.65 umol/L
Standard Deviation 655.38
|
80.44 umol/L
Standard Deviation 0
|
116.69 umol/L
Standard Deviation 32.20
|
195.01 umol/L
Standard Deviation 108.79
|
55.69 umol/L
Standard Deviation 15.14
|
78.30 umol/L
Standard Deviation 40.12
|
65.86 umol/L
Standard Deviation 11.88
|
276.25 umol/L
Standard Deviation 346.92
|
133.14 umol/L
Standard Deviation 140.37
|
—
|
—
|
—
|
Adverse Events
Phase 2: Placebo
Serious events: 39 serious events
Other events: 20 other events
Deaths: 24 deaths
Phase 2: Sarilumab 200mg IV
Serious events: 90 serious events
Other events: 48 other events
Deaths: 60 deaths
Phase 2: Sarilumab 400mg IV
Serious events: 84 serious events
Other events: 44 other events
Deaths: 49 deaths
Phase 3 Cohort 1: Placebo - Critical
Serious events: 89 serious events
Other events: 24 other events
Deaths: 59 deaths
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
Serious events: 119 serious events
Other events: 57 other events
Deaths: 70 deaths
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
Serious events: 183 serious events
Other events: 83 other events
Deaths: 114 deaths
Phase 3 Cohort 1: Placebo - Severe
Serious events: 11 serious events
Other events: 0 other events
Deaths: 9 deaths
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
Serious events: 23 serious events
Other events: 0 other events
Deaths: 12 deaths
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
Serious events: 30 serious events
Other events: 8 other events
Deaths: 21 deaths
Phase 3 Cohort 1: Placebo - MSOD
Serious events: 27 serious events
Other events: 17 other events
Deaths: 16 deaths
Phase 3 Cohort 1: Sarilumab 200 mg IV - MSOD
Serious events: 67 serious events
Other events: 23 other events
Deaths: 40 deaths
Phase 3 Cohort 1: Sarilumab 400 mg IV - MSOD
Serious events: 58 serious events
Other events: 15 other events
Deaths: 40 deaths
Phase 3 Cohort 1: Placebo - Immunocompromised
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 3 Cohort 1: Sarilumab 200 mg IV - Immunocompromised
Serious events: 6 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 3 Cohort 1: Sarilumab 400 mg IV - Immunocompromised
Serious events: 9 serious events
Other events: 6 other events
Deaths: 6 deaths
Phase 3 Cohort 2: Placebo
Serious events: 10 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 3 Cohort 2: Sarilumab 800 mg IV
Serious events: 5 serious events
Other events: 7 other events
Deaths: 3 deaths
Phase 3 Cohort 3: Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 3 Cohort 3: Sarilumab 800 mg IV
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 2: Placebo
n=90 participants at risk
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 2: Sarilumab 200mg IV
n=187 participants at risk
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 2: Sarilumab 400mg IV
n=180 participants at risk
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Placebo - Critical
n=170 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=70 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=140 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=137 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=46 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200 mg IV - MSOD
n=95 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400 mg IV - MSOD
n=92 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=8 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200 mg IV - Immunocompromised
n=12 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400 mg IV - Immunocompromised
n=15 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=15 participants at risk
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 participants at risk
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 participants at risk
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 participants at risk
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia serratia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Tremor
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
5/90 • Number of events 6 • From first dose of study drug to Day 60
|
4.8%
9/187 • Number of events 9 • From first dose of study drug to Day 60
|
5.0%
9/180 • Number of events 9 • From first dose of study drug to Day 60
|
5.9%
10/170 • Number of events 10 • From first dose of study drug to Day 60
|
5.0%
12/242 • Number of events 12 • From first dose of study drug to Day 60
|
3.0%
10/338 • Number of events 10 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
13.3%
2/15 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
16.7%
1/6 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
7.8%
7/90 • Number of events 8 • From first dose of study drug to Day 60
|
4.3%
8/187 • Number of events 8 • From first dose of study drug to Day 60
|
2.2%
4/180 • Number of events 4 • From first dose of study drug to Day 60
|
5.9%
10/170 • Number of events 10 • From first dose of study drug to Day 60
|
2.5%
6/242 • Number of events 6 • From first dose of study drug to Day 60
|
5.0%
17/338 • Number of events 17 • From first dose of study drug to Day 60
|
1.4%
1/70 • Number of events 1 • From first dose of study drug to Day 60
|
2.9%
4/140 • Number of events 4 • From first dose of study drug to Day 60
|
2.9%
4/137 • Number of events 4 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
3.2%
3/95 • Number of events 3 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
16.7%
1/6 • Number of events 1 • From first dose of study drug to Day 60
|
50.0%
1/2 • Number of events 1 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.7%
6/90 • Number of events 8 • From first dose of study drug to Day 60
|
8.0%
15/187 • Number of events 15 • From first dose of study drug to Day 60
|
6.7%
12/180 • Number of events 12 • From first dose of study drug to Day 60
|
8.8%
15/170 • Number of events 15 • From first dose of study drug to Day 60
|
9.5%
23/242 • Number of events 24 • From first dose of study drug to Day 60
|
6.5%
22/338 • Number of events 22 • From first dose of study drug to Day 60
|
2.9%
2/70 • Number of events 2 • From first dose of study drug to Day 60
|
3.6%
5/140 • Number of events 5 • From first dose of study drug to Day 60
|
2.9%
4/137 • Number of events 5 • From first dose of study drug to Day 60
|
4.3%
2/46 • Number of events 2 • From first dose of study drug to Day 60
|
10.5%
10/95 • Number of events 10 • From first dose of study drug to Day 60
|
7.6%
7/92 • Number of events 7 • From first dose of study drug to Day 60
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.4%
4/90 • Number of events 7 • From first dose of study drug to Day 60
|
1.6%
3/187 • Number of events 3 • From first dose of study drug to Day 60
|
2.8%
5/180 • Number of events 5 • From first dose of study drug to Day 60
|
2.4%
4/170 • Number of events 4 • From first dose of study drug to Day 60
|
2.1%
5/242 • Number of events 5 • From first dose of study drug to Day 60
|
3.3%
11/338 • Number of events 11 • From first dose of study drug to Day 60
|
2.9%
2/70 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
4.3%
2/46 • Number of events 2 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
1.6%
3/187 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
0.83%
2/242 • Number of events 2 • From first dose of study drug to Day 60
|
1.2%
4/338 • Number of events 4 • From first dose of study drug to Day 60
|
2.9%
2/70 • Number of events 2 • From first dose of study drug to Day 60
|
1.4%
2/140 • Number of events 2 • From first dose of study drug to Day 60
|
1.5%
2/137 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
2/187 • Number of events 2 • From first dose of study drug to Day 60
|
1.1%
2/180 • Number of events 2 • From first dose of study drug to Day 60
|
2.9%
5/170 • Number of events 5 • From first dose of study drug to Day 60
|
3.3%
8/242 • Number of events 10 • From first dose of study drug to Day 60
|
2.7%
9/338 • Number of events 12 • From first dose of study drug to Day 60
|
1.4%
1/70 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 2 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
1/90 • Number of events 2 • From first dose of study drug to Day 60
|
2.1%
4/187 • Number of events 4 • From first dose of study drug to Day 60
|
2.2%
4/180 • Number of events 4 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
2.5%
6/242 • Number of events 6 • From first dose of study drug to Day 60
|
1.2%
4/338 • Number of events 4 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
2.9%
4/140 • Number of events 4 • From first dose of study drug to Day 60
|
1.5%
2/137 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Cystic lung disease
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar damage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary oedema
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
1.1%
2/180 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
1.8%
3/170 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
1.5%
2/137 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 2 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract oedema
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
COVID-19
|
3.3%
3/90 • Number of events 3 • From first dose of study drug to Day 60
|
7.0%
13/187 • Number of events 13 • From first dose of study drug to Day 60
|
2.8%
5/180 • Number of events 5 • From first dose of study drug to Day 60
|
8.8%
15/170 • Number of events 15 • From first dose of study drug to Day 60
|
7.9%
19/242 • Number of events 19 • From first dose of study drug to Day 60
|
6.8%
23/338 • Number of events 23 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
1.4%
2/140 • Number of events 2 • From first dose of study drug to Day 60
|
3.6%
5/137 • Number of events 5 • From first dose of study drug to Day 60
|
10.9%
5/46 • Number of events 5 • From first dose of study drug to Day 60
|
12.6%
12/95 • Number of events 12 • From first dose of study drug to Day 60
|
9.8%
9/92 • Number of events 10 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
16.7%
2/12 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Staphylococcal infection
|
3.3%
3/90 • Number of events 4 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
2.2%
4/180 • Number of events 4 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.89%
3/338 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Bacteraemia
|
2.2%
2/90 • Number of events 2 • From first dose of study drug to Day 60
|
1.1%
2/187 • Number of events 2 • From first dose of study drug to Day 60
|
1.7%
3/180 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
1.2%
3/242 • Number of events 3 • From first dose of study drug to Day 60
|
0.89%
3/338 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
1.5%
2/137 • Number of events 2 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Bacterial infection
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Bacterial tracheitis
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Endocarditis
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Escherichia infection
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pneumonia
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
2.2%
4/180 • Number of events 4 • From first dose of study drug to Day 60
|
2.9%
5/170 • Number of events 5 • From first dose of study drug to Day 60
|
1.7%
4/242 • Number of events 4 • From first dose of study drug to Day 60
|
1.5%
5/338 • Number of events 5 • From first dose of study drug to Day 60
|
1.4%
1/70 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pneumonia klebsiella
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.83%
2/242 • Number of events 2 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
4.3%
2/46 • Number of events 2 • From first dose of study drug to Day 60
|
3.2%
3/95 • Number of events 4 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Sepsis
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
1.6%
3/187 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
1.2%
3/242 • Number of events 3 • From first dose of study drug to Day 60
|
2.4%
8/338 • Number of events 8 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
4.2%
4/95 • Number of events 4 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Septic shock
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
2.1%
4/187 • Number of events 4 • From first dose of study drug to Day 60
|
1.1%
2/180 • Number of events 2 • From first dose of study drug to Day 60
|
5.3%
9/170 • Number of events 10 • From first dose of study drug to Day 60
|
2.5%
6/242 • Number of events 6 • From first dose of study drug to Day 60
|
3.6%
12/338 • Number of events 12 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
1.5%
2/137 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
4.2%
4/95 • Number of events 4 • From first dose of study drug to Day 60
|
5.4%
5/92 • Number of events 5 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
12.5%
2/16 • Number of events 2 • From first dose of study drug to Day 60
|
16.7%
1/6 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
1.2%
3/242 • Number of events 3 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Achromobacter infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Appendicitis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
1.4%
1/70 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Bronchitis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
2.4%
4/170 • Number of events 4 • From first dose of study drug to Day 60
|
1.2%
3/242 • Number of events 3 • From first dose of study drug to Day 60
|
1.5%
5/338 • Number of events 5 • From first dose of study drug to Day 60
|
2.9%
2/70 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
3.3%
3/92 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
13.3%
2/15 • Number of events 2 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Candida infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
1.1%
2/187 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
1.7%
4/242 • Number of events 4 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Corynebacterium infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Enterobacter infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.89%
3/338 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Enterobacter pneumonia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 2 • From first dose of study drug to Day 60
|
1.2%
3/242 • Number of events 3 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
1.8%
3/170 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Fungaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
1.8%
3/170 • Number of events 3 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Fungal infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Fungal sepsis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Gangrene
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Groin abscess
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.83%
2/242 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Histoplasmosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Lung abscess
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Morganella infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pneumonia acinetobacter
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
1.7%
3/180 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
1.2%
3/242 • Number of events 3 • From first dose of study drug to Day 60
|
0.89%
3/338 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
13.3%
2/15 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pneumonia proteus
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
1.7%
4/242 • Number of events 4 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/90 • From first dose of study drug to Day 60
|
1.6%
3/187 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
0.83%
2/242 • Number of events 2 • From first dose of study drug to Day 60
|
0.89%
3/338 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.83%
2/242 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Serratia infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.83%
2/242 • Number of events 2 • From first dose of study drug to Day 60
|
0.89%
3/338 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Stoma site cellulitis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Urinary tract candidiasis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
1.4%
1/70 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Viral cardiomyopathy
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Cardio-respiratory arrest
|
6.7%
6/90 • Number of events 6 • From first dose of study drug to Day 60
|
5.9%
11/187 • Number of events 11 • From first dose of study drug to Day 60
|
4.4%
8/180 • Number of events 8 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
1.2%
3/242 • Number of events 3 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
2.9%
2/70 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
1.5%
2/137 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Cardiac arrest
|
3.3%
3/90 • Number of events 3 • From first dose of study drug to Day 60
|
4.8%
9/187 • Number of events 9 • From first dose of study drug to Day 60
|
8.9%
16/180 • Number of events 16 • From first dose of study drug to Day 60
|
4.1%
7/170 • Number of events 7 • From first dose of study drug to Day 60
|
2.9%
7/242 • Number of events 8 • From first dose of study drug to Day 60
|
7.4%
25/338 • Number of events 26 • From first dose of study drug to Day 60
|
2.9%
2/70 • Number of events 2 • From first dose of study drug to Day 60
|
2.9%
4/140 • Number of events 4 • From first dose of study drug to Day 60
|
2.2%
3/137 • Number of events 3 • From first dose of study drug to Day 60
|
13.0%
6/46 • Number of events 6 • From first dose of study drug to Day 60
|
9.5%
9/95 • Number of events 9 • From first dose of study drug to Day 60
|
9.8%
9/92 • Number of events 9 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
1.7%
3/180 • Number of events 3 • From first dose of study drug to Day 60
|
1.8%
3/170 • Number of events 3 • From first dose of study drug to Day 60
|
1.2%
3/242 • Number of events 3 • From first dose of study drug to Day 60
|
1.2%
4/338 • Number of events 4 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
3.3%
3/92 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
16.7%
1/6 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Right ventricular failure
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Tachycardia
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.89%
3/338 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
3.3%
3/92 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
1.4%
1/70 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.89%
3/338 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
1.8%
3/170 • Number of events 3 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
16.7%
1/6 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Cerebrovascular accident
|
2.2%
2/90 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
1.5%
2/137 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Encephalopathy
|
2.2%
2/90 • Number of events 2 • From first dose of study drug to Day 60
|
1.1%
2/187 • Number of events 2 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Depressed level of consciousness
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Seizure
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
1.4%
1/70 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Alcoholic seizure
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Brachial plexopathy
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.89%
3/338 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Cerebral artery embolism
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.83%
2/242 • Number of events 3 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Encephalitis haemorrhagic
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Lethargy
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Presyncope
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Seizure like phenomena
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Renal and urinary disorders
Renal failure
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
2.1%
4/187 • Number of events 4 • From first dose of study drug to Day 60
|
1.1%
2/180 • Number of events 2 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
1.7%
4/242 • Number of events 4 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
1.5%
2/137 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
3.2%
3/95 • Number of events 3 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Alanine aminotransferase increased
|
2.2%
2/90 • Number of events 2 • From first dose of study drug to Day 60
|
1.1%
2/187 • Number of events 2 • From first dose of study drug to Day 60
|
2.2%
4/180 • Number of events 4 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
1.7%
4/242 • Number of events 4 • From first dose of study drug to Day 60
|
1.2%
4/338 • Number of events 4 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
2.2%
3/137 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
3.3%
3/92 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
2/187 • Number of events 2 • From first dose of study drug to Day 60
|
1.7%
3/180 • Number of events 3 • From first dose of study drug to Day 60
|
2.4%
4/170 • Number of events 4 • From first dose of study drug to Day 60
|
1.7%
4/242 • Number of events 4 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
1.4%
2/140 • Number of events 2 • From first dose of study drug to Day 60
|
2.2%
3/137 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
4.3%
4/92 • Number of events 4 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Klebsiella test positive
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Transaminases increased
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
3.2%
6/187 • Number of events 6 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
1.2%
3/242 • Number of events 3 • From first dose of study drug to Day 60
|
1.2%
4/338 • Number of events 5 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
4.3%
2/46 • Number of events 2 • From first dose of study drug to Day 60
|
3.2%
3/95 • Number of events 3 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Blood potassium increased
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Body temperature increased
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Electrocardiogram change
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Enterobacter test positive
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Enterococcus test positive
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Liver function test abnormal
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Liver function test increased
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Platelet count increased
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
1.1%
2/180 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
2/187 • Number of events 2 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
1.2%
4/338 • Number of events 4 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
1.1%
2/187 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Deep vein thrombosis
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
2.1%
4/187 • Number of events 6 • From first dose of study drug to Day 60
|
5.0%
9/180 • Number of events 11 • From first dose of study drug to Day 60
|
2.4%
4/170 • Number of events 4 • From first dose of study drug to Day 60
|
3.3%
8/242 • Number of events 8 • From first dose of study drug to Day 60
|
3.6%
12/338 • Number of events 12 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
2.2%
2/92 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
16.7%
1/6 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Haemorrhage
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Distributive shock
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Dry gangrene
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Embolism
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Haematoma
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Hypertension
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
1.7%
3/180 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.59%
2/338 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Hypotension
|
0.00%
0/90 • From first dose of study drug to Day 60
|
2.1%
4/187 • Number of events 5 • From first dose of study drug to Day 60
|
1.7%
3/180 • Number of events 3 • From first dose of study drug to Day 60
|
3.5%
6/170 • Number of events 6 • From first dose of study drug to Day 60
|
2.5%
6/242 • Number of events 7 • From first dose of study drug to Day 60
|
3.0%
10/338 • Number of events 10 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
5.4%
5/92 • Number of events 5 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.83%
2/242 • Number of events 2 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Shock
|
0.00%
0/90 • From first dose of study drug to Day 60
|
1.1%
2/187 • Number of events 2 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
1.5%
5/338 • Number of events 5 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Thrombosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
2.2%
4/180 • Number of events 5 • From first dose of study drug to Day 60
|
2.4%
4/170 • Number of events 4 • From first dose of study drug to Day 60
|
1.2%
3/242 • Number of events 3 • From first dose of study drug to Day 60
|
1.2%
4/338 • Number of events 4 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
20.0%
3/15 • Number of events 3 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.83%
2/242 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
1.7%
3/180 • Number of events 3 • From first dose of study drug to Day 60
|
1.2%
2/170 • Number of events 2 • From first dose of study drug to Day 60
|
1.2%
3/242 • Number of events 3 • From first dose of study drug to Day 60
|
1.5%
5/338 • Number of events 5 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.83%
2/242 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
2.1%
2/95 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
2/187 • Number of events 2 • From first dose of study drug to Day 60
|
2.2%
4/180 • Number of events 4 • From first dose of study drug to Day 60
|
2.4%
4/170 • Number of events 4 • From first dose of study drug to Day 60
|
1.7%
4/242 • Number of events 4 • From first dose of study drug to Day 60
|
3.0%
10/338 • Number of events 11 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
2.9%
4/137 • Number of events 5 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
3.2%
3/95 • Number of events 3 • From first dose of study drug to Day 60
|
4.3%
4/92 • Number of events 4 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
13.3%
2/15 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
General disorders
Asthenia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
General disorders
Chest pain
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
1.4%
1/70 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
General disorders
Death
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.73%
1/137 • Number of events 1 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
General disorders
Device related thrombosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
General disorders
Pneumatosis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
General disorders
Pyrexia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
1.4%
1/70 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Immune system disorders
Cytokine storm
|
1.1%
1/90 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Congenital, familial and genetic disorders
Antithrombin III deficiency
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.83%
2/242 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
1.1%
1/92 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
1.4%
1/70 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.56%
1/180 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.71%
1/140 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Product Issues
Device dislocation
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Psychiatric disorders
Agitation
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.59%
1/170 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Psychiatric disorders
Delirium
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
2.2%
1/46 • Number of events 1 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Psychiatric disorders
Neuropsychiatric symptoms
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.53%
1/187 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
1.1%
1/95 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Skin and subcutaneous tissue disorders
Livedo reticularis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.30%
1/338 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.41%
1/242 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
Other adverse events
| Measure |
Phase 2: Placebo
n=90 participants at risk
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 2: Sarilumab 200mg IV
n=187 participants at risk
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 2: Sarilumab 400mg IV
n=180 participants at risk
Hospitalized with SARS-CoV-2 infection and one of the following disease strata:
* Severe disease
* Critical disease
* Multi-system organ dysfunction/Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Placebo - Critical
n=170 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Critical
n=242 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Critical
n=338 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Critical disease (suppl. O2 by non-rebreather/high-flow cannula or invasive/non-invasive ventilation or treatment in ICU)
|
Phase 3 Cohort 1: Placebo - Severe
n=70 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 200mg IV - Severe
n=140 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Sarilumab 400mg IV - Severe
n=137 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Severe disease (suppl. O2 by nasal cannula, face mask, or similar O2 delivery device)
|
Phase 3 Cohort 1: Placebo - MSOD
n=46 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 200 mg IV - MSOD
n=95 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Sarilumab 400 mg IV - MSOD
n=92 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Multi-system organ dysfunction (MSOD) \[vasopressors, extracorporeal life support, or renal replacement therapy\]
|
Phase 3 Cohort 1: Placebo - Immunocompromised
n=8 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 200 mg IV - Immunocompromised
n=12 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 1: Sarilumab 400 mg IV - Immunocompromised
n=15 participants at risk
Hospitalized with SARS-CoV-2 infection and in the following disease strata:
-Immunocompromised or on immunosuppressive treatment
|
Phase 3 Cohort 2: Placebo
n=15 participants at risk
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 2: Sarilumab 800 mg IV
n=16 participants at risk
Hospitalized with SARS-CoV-2 infection requiring mechanical ventilation due to COVID-19
|
Phase 3 Cohort 3: Placebo
n=6 participants at risk
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
Phase 3 Cohort 3: Sarilumab 800 mg IV
n=2 participants at risk
Hospitalized with SARS-CoV-2 infection requiring high-Intensity oxygen therapy without Mechanical Ventilation at baseline
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
15/90 • Number of events 18 • From first dose of study drug to Day 60
|
16.0%
30/187 • Number of events 32 • From first dose of study drug to Day 60
|
16.7%
30/180 • Number of events 31 • From first dose of study drug to Day 60
|
9.4%
16/170 • Number of events 17 • From first dose of study drug to Day 60
|
14.9%
36/242 • Number of events 38 • From first dose of study drug to Day 60
|
10.7%
36/338 • Number of events 40 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
26.1%
12/46 • Number of events 15 • From first dose of study drug to Day 60
|
12.6%
12/95 • Number of events 15 • From first dose of study drug to Day 60
|
10.9%
10/92 • Number of events 13 • From first dose of study drug to Day 60
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
13.3%
2/15 • Number of events 2 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
12.5%
2/16 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Alanine aminotransferase increased
|
14.4%
13/90 • Number of events 15 • From first dose of study drug to Day 60
|
20.3%
38/187 • Number of events 41 • From first dose of study drug to Day 60
|
16.7%
30/180 • Number of events 32 • From first dose of study drug to Day 60
|
11.2%
19/170 • Number of events 19 • From first dose of study drug to Day 60
|
17.4%
42/242 • Number of events 46 • From first dose of study drug to Day 60
|
15.1%
51/338 • Number of events 53 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
5.8%
8/137 • Number of events 8 • From first dose of study drug to Day 60
|
19.6%
9/46 • Number of events 9 • From first dose of study drug to Day 60
|
7.4%
7/95 • Number of events 7 • From first dose of study drug to Day 60
|
12.0%
11/92 • Number of events 13 • From first dose of study drug to Day 60
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Liver function test increased
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
6.5%
3/46 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
25.0%
3/12 • Number of events 3 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Investigations
Transaminases increased
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
7.1%
24/338 • Number of events 25 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Acinetobacter infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
13.3%
2/15 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Fungaemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
13.3%
2/15 • Number of events 2 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Fungal infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pneumonia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
5.3%
5/95 • Number of events 5 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
8.3%
1/12 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
16.7%
1/6 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
6.5%
3/46 • Number of events 3 • From first dose of study drug to Day 60
|
6.3%
6/95 • Number of events 6 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.2%
1/16 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
50.0%
1/2 • Number of events 1 • From first dose of study drug to Day 60
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
0.00%
0/8 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
50.0%
1/2 • Number of events 1 • From first dose of study drug to Day 60
|
|
Vascular disorders
Hypotension
|
0.00%
0/90 • From first dose of study drug to Day 60
|
0.00%
0/187 • From first dose of study drug to Day 60
|
0.00%
0/180 • From first dose of study drug to Day 60
|
0.00%
0/170 • From first dose of study drug to Day 60
|
0.00%
0/242 • From first dose of study drug to Day 60
|
0.00%
0/338 • From first dose of study drug to Day 60
|
0.00%
0/70 • From first dose of study drug to Day 60
|
0.00%
0/140 • From first dose of study drug to Day 60
|
0.00%
0/137 • From first dose of study drug to Day 60
|
0.00%
0/46 • From first dose of study drug to Day 60
|
0.00%
0/95 • From first dose of study drug to Day 60
|
0.00%
0/92 • From first dose of study drug to Day 60
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to Day 60
|
0.00%
0/12 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/15 • From first dose of study drug to Day 60
|
0.00%
0/16 • From first dose of study drug to Day 60
|
0.00%
0/6 • From first dose of study drug to Day 60
|
0.00%
0/2 • From first dose of study drug to Day 60
|
Additional Information
Clinical Trials Adminstrator
Regeneron Pharmaceuticals, Inc.
Phone: 844-734-6643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER