Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19) (NCT NCT04745351)
NCT ID: NCT04745351
Last Updated: 2023-05-12
Results Overview
This is the combined outcome measure reporting the percentage of participants with all-cause death or IMV through Day 29. The reported percentage was from the Kaplan-Meier estimate.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
249 participants
Primary outcome timeframe
First dose date up to Day 29
Results posted on
2023-05-12
Participant Flow
Participants were enrolled at study sites in Brazil, Portugal, Spain, the United Kingdom, and the United States.
258 participants were screened.
Participant milestones
| Measure |
Remdesivir (RDV)
Participants received continued Standard of Care (SOC) therapy together with RDV 200 mg intravenous (IV) infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
83
|
|
Overall Study
COMPLETED
|
95
|
50
|
|
Overall Study
NOT COMPLETED
|
71
|
33
|
Reasons for withdrawal
| Measure |
Remdesivir (RDV)
Participants received continued Standard of Care (SOC) therapy together with RDV 200 mg intravenous (IV) infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Overall Study
Death
|
51
|
25
|
|
Overall Study
Lost to Follow-up
|
9
|
3
|
|
Overall Study
Randomized but Never Treated
|
3
|
3
|
|
Overall Study
Adverse Event
|
4
|
0
|
|
Overall Study
Withdrew Consent
|
1
|
2
|
|
Overall Study
Investigator's Discretion
|
2
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19)
Baseline characteristics by cohort
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
71 years
STANDARD_DEVIATION 13.0 • n=107 Participants
|
69 years
STANDARD_DEVIATION 13.8 • n=206 Participants
|
|
Age, Customized
Age Categorical · < 18 Years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Customized
Age Categorical · >= 18 to < 65 Years
|
70 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Age, Customized
Age Categorical · >= 65 Years
|
93 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
135 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
207 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
43 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
104 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
159 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
121 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
26 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Region of Enrollment
Portugal
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Clinical Status (8-point Ordinal Scale)
Score: 1
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Clinical Status (8-point Ordinal Scale)
Score: 2
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Clinical Status (8-point Ordinal Scale)
Score: 3
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Clinical Status (8-point Ordinal Scale)
Score: 4
|
36 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Clinical Status (8-point Ordinal Scale)
Score: 5
|
97 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
144 Participants
n=206 Participants
|
|
Clinical Status (8-point Ordinal Scale)
Score: 6
|
30 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Clinical Status (8-point Ordinal Scale)
Score: 7
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Clinical Status (8-point Ordinal Scale)
Score: 8
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: First dose date up to Day 29Population: Full Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
This is the combined outcome measure reporting the percentage of participants with all-cause death or IMV through Day 29. The reported percentage was from the Kaplan-Meier estimate.
Outcome measures
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Percentage of Participants With All-cause Death or Invasive Mechanical Ventilation (IMV) Through Day 29
|
30.2 percentage of participants
|
33.5 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to Day 29Population: Participants in the Full Analysis Set were analyzed.
The reported percentage was from the Kaplan-Meier estimate.
Outcome measures
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
All-cause Mortality Through Day 29
|
25.9 percentage of participants
|
29.7 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to Day 29Population: Participants in the Full Analysis Set were analyzed.
The reported percentage was the cumulative-incidence estimate.
Outcome measures
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Percentage of Participants With Initiation of IMV Through Day 29
|
13.8 percentage of participants
|
12.8 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to Day 29Population: Participants in the Full Analysis Set were analyzed.
Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 8) Death. Cumulative incidence was reported.
Outcome measures
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Time to Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) by Day 29
|
20 days
Interval 7.0 to
Upper bound of range (Q3) was not estimable due to less than 75% of participants with recovery.
|
19 days
Interval 7.0 to
Upper bound of range (Q3) was not estimable due to less than 75% of participants with recovery.
|
SECONDARY outcome
Timeframe: First dose date up to Day 29Population: Participants in the Full Analysis Set were analyzed.
Time to recovery is the time from first dose to recovery. Recovery is defined as the first day on which the participant with a baseline score ≥ 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Cumulative incidence was reported.
Outcome measures
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Time to Recovery Independent of Further Worsening by Day 29
|
10 days
Interval 6.0 to
Q3 was not estimable due to less than 75% of participants with recovery.
|
13 days
Interval 6.0 to
Q3 was not estimable due to less than 75% of participants with recovery.
|
SECONDARY outcome
Timeframe: Day 15Population: Participants in the Full Analysis Set were analyzed.
Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Outcome measures
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Score: 1
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Score: 2
|
48.5 percentage of participants
|
48.8 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Score: 3
|
5.5 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Score: 4
|
9.2 percentage of participants
|
7.5 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Score: 5
|
6.1 percentage of participants
|
11.3 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Score: 6
|
8.0 percentage of participants
|
5.0 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Score: 7
|
4.9 percentage of participants
|
6.3 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 15
Score: 8
|
17.8 percentage of participants
|
18.8 percentage of participants
|
SECONDARY outcome
Timeframe: Day 29Population: Participants in the Full Analysis Set were analyzed.
Clinical status is derived from death, hospital discharge, and the ordinal scale. Each day, the worst (highest) score from the previous day was recorded. The 8-point Ordinal scale is as follows: 1. Not hospitalized, no limitations on activities; 2. Not hospitalized, limitation on activities and/or requiring home oxygen; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per-protocol RDV/saline as placebo administration); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19-specific medical care (other than per-protocol RDV administration); 5. Hospitalized, supplemental oxygen; 6. Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on IMV or ECMO; and 8. Death. Higher scores indicate worse clinical status.
Outcome measures
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Score: 6
|
1.8 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Score: 1
|
11.7 percentage of participants
|
16.3 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Score: 2
|
42.9 percentage of participants
|
45.0 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Score: 3
|
3.1 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Score: 4
|
4.3 percentage of participants
|
1.3 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Score: 5
|
9.2 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Score: 7
|
1.8 percentage of participants
|
2.5 percentage of participants
|
|
Percentage of Participants Within Each Clinical Status Category as Assessed by an 8-Point Ordinal Scale on Day 29
Score: 8
|
25.2 percentage of participants
|
28.8 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to Day 29Population: Participants without ESKD at baseline in the Full Analysis Set with available data were analyzed.
The number of RRT free days were calculated as the number of full days from Day 1 to Day 29 on which the participant was alive and did not receive RRT.
Outcome measures
| Measure |
Remdesivir (RDV)
n=104 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=50 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Renal Replacement Therapy (RRT)-Free Days (Among Those Without End-Stage Kidney Disease [ESKD] at Baseline) Through Day 29
|
29 days
Interval 1.0 to 29.0
|
29 days
Interval 4.0 to 29.0
|
SECONDARY outcome
Timeframe: First dose date up to Day 29Population: Participants in the Full Analysis Set were analyzed.
Recovery is defined as the first day on which the participant with a baseline score \>= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Outcome measures
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Percentage of Participants With Recovery Without Subsequent Worsening (Defined as an Ordinal Scale Score of > 4) Through Day 29
|
57.7 percentage of participants
|
63.8 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to Day 29Population: Participants in the Full Analysis Set were analyzed.
Recovery is defined as the first day on which the participant with a baseline score \>= 4, satisfies categories 1, 2, or 3 from the 8-point ordinal scale including: 1) Non-hospitalized, no limitations on activities; 2) Non-hospitalized, limitations on activities/requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care for COVID-19; 5) Hospitalized, supplemental oxygen; 6) Hospitalized, on noninvasive ventilation; 7) Hospitalized, on IMV or ECMO; 8) Death.
Outcome measures
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Percentage of Participants With Recovery Independent of Further Worsening Through Day 29
|
66.3 percentage of participants
|
67.5 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to last dose date (Maximum: 5 days) plus 30 daysPopulation: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
An SAE was defined as an event that, at any dose, results in the following: Death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect, a medically important event or reaction which may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes constituting SAEs.
Outcome measures
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
|
50.3 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to last dose date (Maximum: 5 days)Population: Participants in the Safety Analysis Set were analyzed.
An AE is any untoward medical occurrence in a clinical study participant administered an investigational drug, which does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of an investigational drug, whether or not the AE is considered related to the investigational drug.
Outcome measures
| Measure |
Remdesivir (RDV)
n=163 Participants
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 Participants
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Investigational Drug Due to Adverse Events (AEs)
|
4.9 percentage of participants
|
1.3 percentage of participants
|
Adverse Events
Remdesivir (RDV)
Serious events: 82 serious events
Other events: 60 other events
Deaths: 55 deaths
Placebo
Serious events: 40 serious events
Other events: 34 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Remdesivir (RDV)
n=163 participants at risk
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 participants at risk
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
1.8%
3/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrioventricular block
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
4.9%
8/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
3.8%
3/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiogenic shock
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Pulseless electrical activity
|
1.8%
3/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.5%
4/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
General disorders
Sudden death
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatic ischaemia
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Aspergillus infection
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
1.8%
3/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteroides bacteraemia
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
3.8%
3/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Covid-19 pneumonia
|
1.8%
3/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Device related bacteraemia
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Endocarditis bacterial
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Gangrene
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Postoperative abscess
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Pulmonary sepsis
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis acute
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
3.1%
5/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
2.5%
2/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
3.7%
6/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
2.5%
2/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Superinfection bacterial
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Dialysis related complication
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Investigations
Glomerular filtration rate abnormal
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Investigations
Lipase increased
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
2.5%
2/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
2.5%
2/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Nervous system disorders
Dementia
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Nervous system disorders
Depressed level of consciousness
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
5/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
2.5%
2/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
6.1%
10/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
5.0%
4/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.7%
6/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
2.5%
2/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
2.5%
2/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
3.8%
3/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
2.5%
2/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.8%
3/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.3%
7/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
12.5%
10/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
4.3%
7/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Vascular disorders
Malignant hypertension
|
0.61%
1/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Vascular disorders
Shock
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
0.00%
0/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Remdesivir (RDV)
n=163 participants at risk
Participants received continued SOC therapy together with RDV 200 mg IV infusion on Day 1 followed by RDV 100 mg IV infusion from Day 2 up to Day 5.
|
Placebo
n=80 participants at risk
Participants received continued SOC therapy together with RDV matching placebo IV saline on Day 1 followed by RDV matching placebo IV saline from Day 2 up to Day 5.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
10/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
7/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
5.0%
4/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
7.4%
12/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
8.8%
7/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
7.4%
12/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
3.8%
3/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.3%
7/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
6.2%
5/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.0%
13/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
1.2%
1/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.9%
8/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
5.0%
4/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.1%
5/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
8.8%
7/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.8%
3/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
5.0%
4/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
5.0%
4/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
1.8%
3/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
5.0%
4/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
3.1%
5/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
5.0%
4/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
3.1%
5/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
8.8%
7/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.5%
4/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
7.5%
6/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
7.4%
12/163 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
5.0%
4/80 • All-Cause Mortality: Randomization up to last follow-up visit (maximum of 15 weeks); Adverse Events: First dose date up to last dose date (maximum: 5 days) plus 30 days
All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse Events: Safety Analysis Set included all participants who were randomized into the study and had received at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years.
- Publication restrictions are in place
Restriction type: OTHER