Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia (NCT NCT04320615)
NCT ID: NCT04320615
Last Updated: 2021-06-30
Results Overview
Clinical status was assessed using a 7-category ordinal scale: 1. \- Discharged (or "ready for discharge") 2. \- Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen 3. \- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen 4. \- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen 5. \- ICU, requiring intubation and mechanical ventilation 6. \- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support 7. \- Death
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
452 participants
Primary outcome timeframe
Day 28
Results posted on
2021-06-30
Participant Flow
452 participants were randomized in the study. Of the 452 participants enrolled, 14 were randomized but not dosed and therefore discontinued from the study.
Participant milestones
| Measure |
Placebo Modified Intent-to-Treat (mITT) Arm
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Tocilizumab (TCZ) mITT Arm
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
294
|
|
Overall Study
COMPLETED
|
96
|
190
|
|
Overall Study
NOT COMPLETED
|
48
|
104
|
Reasons for withdrawal
| Measure |
Placebo Modified Intent-to-Treat (mITT) Arm
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Tocilizumab (TCZ) mITT Arm
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
10
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Other
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
23
|
|
Overall Study
Death
|
35
|
71
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Baseline characteristics by cohort
| Measure |
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Total
n=438 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 Years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
60.9 Years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
60.8 Years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
306 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
47 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
86 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
252 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Clinical status was assessed using a 7-category ordinal scale: 1. \- Discharged (or "ready for discharge") 2. \- Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen 3. \- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen 4. \- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen 5. \- ICU, requiring intubation and mechanical ventilation 6. \- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support 7. \- Death
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4)
2
|
2.0 Percentage of Participants
|
5.6 Percentage of Participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4)
3
|
4.8 Percentage of Participants
|
2.8 Percentage of Participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4)
1
|
56.5 Percentage of Participants
|
49.3 Percentage of Participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4)
4
|
2.0 Percentage of Participants
|
6.9 Percentage of Participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4)
5
|
8.8 Percentage of Participants
|
9.7 Percentage of Participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4)
6
|
6.1 Percentage of Participants
|
6.3 Percentage of Participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4)
7
|
19.7 Percentage of Participants
|
19.4 Percentage of Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Defined as time from first dose of study drug to at least two NEWS2 assessments with a score of \<=2 covering a span of at least 21.5 hours, with a maximum of 26.5 hours between the first and last of these assessments and no assessments with a score \>2 in between. If one of the components of the NEWS2 score was missing at a particular time point, then the NEWS2 score was not calculated. Participants who died were censored at Day 28.
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Time to Clinical Improvement (TTCI), Defined as a National Early Warning Score 2 (NEWS2) of </= 2 Maintained for 24 Hours
|
NA Days
NA = Value not estimable (NE) due to an insufficient number of events.
|
NA Days
NA = Value not estimable (NE) due to an insufficient number of events.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Time to improvement for this outcome measure was defined as the days from the first dose of study drug to when at least a 2-category improvement in clinical status (based on a 7-category ordinal scale) is observed. Participants who died were censored at Day 28.
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status
|
14.0 Days
Interval 12.0 to 17.0
|
18.0 Days
Interval 15.0 to 28.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Time to Hospital Discharge was defined as the time from the first dose of study drug to hospital discharge or "ready for discharge" (normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or \</=2L supplemental oxygen) Participants who died were censored at Day 28.
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Time to Hospital Discharge or "Ready for Discharge"
|
20.0 Days
Interval 17.0 to 27.0
|
28.0 Days
Interval 20.0 to
NA = Value not estimable (NE) due to an insufficient number of events.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Participants who died by Day 28 were assumed to have required mechanical ventilation.
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
n=183 Participants
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
n=90 Participants
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Incidence of Mechanical Ventilation by Day 28
|
54.4 Percentage of Participants
Interval 48.7 to 60.1
|
60.4 Percentage of Participants
Interval 52.4 to 68.4
|
27.9 Percentage of Participants
Interval 21.4 to 34.4
|
36.7 Percentage of Participants
Interval 26.7 to 46.6
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Participants who died by Day 28 were assigned 0 ventilator-free days.
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Ventilator-Free Days to Day 28
|
22.0 Days
Interval 18.0 to 28.0
|
16.5 Days
Interval 11.0 to 26.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Participants who died by Day 28 were assumed to have required an ICU stay.
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
n=127 Participants
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
n=64 Participants
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Incidence of Intensive Care Unit (ICU) Stay by Day 28 (Week 4)
|
66.0 Percentage of Participants
Interval 60.6 to 71.4
|
71.5 Percentage of Participants
Interval 64.2 to 78.9
|
21.3 Percentage of Participants
Interval 14.1 to 28.4
|
35.9 Percentage of Participants
Interval 24.2 to 47.7
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Participants who died by Day 28 were assigned a duration from the first dose of study drug to Day 28 at hour 23:59:59.
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Duration of ICU Stay to Day 28 (Week 4)
|
9.8 Days
Interval 7.0 to 15.7
|
15.5 Days
Interval 8.7 to 25.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 14Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Clinical status was assessed using a 7-category ordinal scale: 1. \- Discharged (or "ready for discharge") 2. \- Non- intensive care unit (ICU) hospital ward (or "ready for hospital ward") not requiring supplemental oxygen 3. \- Non-ICU hospital ward (or "ready for hospital ward") requiring supplemental oxygen 4. \- ICU or non-ICU hospital ward, requiring non-invasive ventilation or high-flow oxygen 5. \- ICU, requiring intubation and mechanical ventilation 6. \- ICU, requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support 7. \- Death
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 14
1
|
39.8 Percentage of participants
|
29.9 Percentage of participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 14
2
|
6.1 Percentage of participants
|
4.9 Percentage of participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 14
3
|
6.5 Percentage of participants
|
11.1 Percentage of participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 14
6
|
12.6 Percentage of participants
|
17.4 Percentage of participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 14
4
|
7.1 Percentage of participants
|
7.6 Percentage of participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 14
5
|
14.6 Percentage of participants
|
16.0 Percentage of participants
|
—
|
—
|
|
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 14
7
|
13.3 Percentage of participants
|
13.2 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Time to clinical failure was defined as the number of days from the first dose of study drug to the first occurrence on study of death, mechanical ventilation, ICU admission, or study withdrawal prior to discharge, whichever occurs first.
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Time to Clinical Failure to Day 28 (Week 4)
|
NA Days
NA = Value not estimable (NE) due to an insufficient number of events.
|
NA Days
Interval 21.0 to
NA = Value not estimable (NE) due to an insufficient number of events.
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Mortality Rate at Day 28 (Week 4)
|
19.7 Percentage of Participants
Interval 15.2 to 24.3
|
19.4 Percentage of Participants
Interval 13.0 to 25.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Time to recovery was defined as the number of days from the first dose of study drug to hospital discharge or "ready for discharge" (normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or \</= 2L supplemental oxygen) or non-ICU hospital ward or "ready for hospital ward" not requiring supplemental oxygen. Participants who died were censored at Day 28.
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Time to Recovery to Day 28 (Week 4)
|
16.0 Days
Interval 12.0 to 21.0
|
24.0 Days
Interval 18.0 to
NA = Value not estimable (NE) due to an insufficient number of events.
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 28Population: mITT population: Defined as all randomized participants who received any amount of study medication, with participants grouped according to the treatment assigned at randomization.
Participants who died by Day 28 were assigned a duration of 28 days of supplemental oxygen.
Outcome measures
| Measure |
Tocilizumab (TCZ) mITT Arm
n=294 Participants
Participants randomized to the TCZ arm who received any amount of study drug. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo Modified Intent-to-Treat (mITT) Arm
n=144 Participants
Participants randomized to the placebo arm who received any amount of study drug. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
TCZ - No Mechanical Ventilation at Baseline
Participants randomized to the TCZ arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the TCZ arm were to receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
Placebo - No Mechanical Ventilation at Baseline
Participants randomized to the placebo arm who received any amount of study drug and were not on mechanical ventilation at baseline. Participants randomized to the placebo arm were to receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose could be given if clinical symptoms worsened or showed no improvement.
|
|---|---|---|---|---|
|
Duration of Supplemental Oxygen to Day 28 (Week 4)
|
26.5 Days
Interval 19.0 to 28.0
|
28.0 Days
Interval 26.0 to 28.0
|
—
|
—
|
Adverse Events
Placebo Arm (Safety-Evaluable Population)
Serious events: 64 serious events
Other events: 29 other events
Deaths: 36 deaths
Tocilizumab (TCZ) Arm (Safety-Evaluable Population)
Serious events: 116 serious events
Other events: 83 other events
Deaths: 72 deaths
Serious adverse events
| Measure |
Placebo Arm (Safety-Evaluable Population)
n=143 participants at risk
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
Tocilizumab (TCZ) Arm (Safety-Evaluable Population)
n=295 participants at risk
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|---|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
1.4%
4/295 • Number of events 4 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
1.0%
3/295 • Number of events 3 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Bradycardia
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Cardiac arrest
|
3.5%
5/143 • Number of events 6 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
1.4%
4/295 • Number of events 4 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.68%
2/295 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Pulseless electrical activity
|
1.4%
2/143 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.68%
2/295 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Gastrointestinal disorders
Abdominal hernia perforation
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Gastrointestinal disorders
Melaena
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.68%
2/295 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.68%
2/295 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
1.7%
5/295 • Number of events 5 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
General disorders
Pyrexia
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Bacteraemia
|
2.1%
3/143 • Number of events 3 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
1.0%
3/295 • Number of events 3 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
1.0%
3/295 • Number of events 3 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Bronchitis
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
COVID-19
|
1.4%
2/143 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
4.7%
14/295 • Number of events 14 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
COVID-19 pneumonia
|
14.0%
20/143 • Number of events 20 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
12.2%
36/295 • Number of events 36 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Candida infection
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Cytomegalovirus hepatitis
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Device related infection
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Empyema
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Enterobacter pneumonia
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Escherichia infection
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Infection
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Osteomyelitis
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Pneumonia
|
2.8%
4/143 • Number of events 5 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
2.4%
7/295 • Number of events 8 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Pneumonia bacterial
|
1.4%
2/143 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
2.0%
6/295 • Number of events 6 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Sepsis
|
2.8%
4/143 • Number of events 4 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
1.0%
3/295 • Number of events 3 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Septic shock
|
4.9%
7/143 • Number of events 8 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
2.4%
7/295 • Number of events 7 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Staphylococcal infection
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Stenotrophomonas infection
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Tracheobronchitis bacterial
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.68%
2/295 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Urosepsis
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Injury, poisoning and procedural complications
Transfusion-related acute lung injury
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Investigations
Citrobacter test positive
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Investigations
Enterococcus test positive
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Nervous system disorders
Cerebral infarction
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Nervous system disorders
Seizure
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Psychiatric disorders
Delirium
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.68%
2/295 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.8%
4/143 • Number of events 4 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
3.4%
10/295 • Number of events 10 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Renal and urinary disorders
Renal failure
|
1.4%
2/143 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.68%
2/295 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.4%
2/143 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
1.4%
4/295 • Number of events 4 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
2/143 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.68%
2/295 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
3/143 • Number of events 3 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
1.4%
2/143 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.00%
0/295 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.1%
3/143 • Number of events 3 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
1.4%
4/295 • Number of events 5 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
2/143 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
1.7%
5/295 • Number of events 5 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.2%
6/143 • Number of events 6 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
1.7%
5/295 • Number of events 5 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Vascular disorders
Haematoma
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Vascular disorders
Hypertension
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Vascular disorders
Hypotension
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/143 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.34%
1/295 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Vascular disorders
Shock haemorrhagic
|
0.70%
1/143 • Number of events 1 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
0.68%
2/295 • Number of events 2 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
Other adverse events
| Measure |
Placebo Arm (Safety-Evaluable Population)
n=143 participants at risk
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
Tocilizumab (TCZ) Arm (Safety-Evaluable Population)
n=295 participants at risk
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.0%
10/143 • Number of events 10 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
5.8%
17/295 • Number of events 17 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
8/143 • Number of events 8 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
6.1%
18/295 • Number of events 18 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
3/143 • Number of events 3 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
6.1%
18/295 • Number of events 18 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Pneumonia
|
5.6%
8/143 • Number of events 12 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
3.4%
10/295 • Number of events 10 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
5/143 • Number of events 6 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
7.5%
22/295 • Number of events 22 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
|
Vascular disorders
Hypertension
|
2.1%
3/143 • Number of events 4 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
6.8%
20/295 • Number of events 24 • 60 days
The safety-evaluable population consisted of all participants who received any amount of study medication. Participants are grouped according to the treatment first received rather than the treatment assigned at randomization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER