Trial Outcomes & Findings for Adaptive COVID-19 Treatment Trial 2 (ACTT-2) (NCT NCT04401579)
NCT ID: NCT04401579
Last Updated: 2022-03-14
Results Overview
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1033 participants
Primary outcome timeframe
Day 1 through Day 29
Results posted on
2022-03-14
Participant Flow
Participants were recruited at the participating sites from those admitted with symptoms of COVID-19 confirmed by PCR. Enrollment occurred between 08May2020 and 01Jul2020.
Participant milestones
| Measure |
Remdesivir Plus Baricitinib
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Baricitinib: Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name \[1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl\]acetonitrile Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
|
Remdesivir Plus Placebo
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Placebo: The matching Baricitinib placebo contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The coating for the placebo tablet is identical to that of the corresponding active tablet
|
|---|---|---|
|
Overall Study
STARTED
|
515
|
518
|
|
Overall Study
Treated
|
507
|
509
|
|
Overall Study
COMPLETED
|
431
|
408
|
|
Overall Study
NOT COMPLETED
|
84
|
110
|
Reasons for withdrawal
| Measure |
Remdesivir Plus Baricitinib
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Baricitinib: Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name \[1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl\]acetonitrile Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
|
Remdesivir Plus Placebo
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
Remdesivir: Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Placebo: The matching Baricitinib placebo contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The coating for the placebo tablet is identical to that of the corresponding active tablet
|
|---|---|---|
|
Overall Study
Death
|
23
|
36
|
|
Overall Study
Lost to Follow-up
|
40
|
41
|
|
Overall Study
Withdrawal by Subject
|
8
|
16
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Became ineligible after enrollment
|
1
|
1
|
|
Overall Study
Enrolled but treatment not administered
|
7
|
9
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Scheduling error
|
1
|
2
|
|
Overall Study
Transferred to another hospital
|
1
|
2
|
Baseline Characteristics
Adaptive COVID-19 Treatment Trial 2 (ACTT-2)
Baseline characteristics by cohort
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Total
n=1033 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
368 Participants
n=5 Participants
|
360 Participants
n=7 Participants
|
728 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
147 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
55.8 years
STANDARD_DEVIATION 16.0 • n=7 Participants
|
55.4 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
381 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
319 Participants
n=5 Participants
|
333 Participants
n=7 Participants
|
652 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
263 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
531 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
246 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
486 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
77 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
251 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
496 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
132 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
441 Participants
n=5 Participants
|
444 Participants
n=7 Participants
|
885 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
35 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Disease severity
Severe Disease Severity
|
176 Participants
n=5 Participants
|
191 Participants
n=7 Participants
|
367 Participants
n=5 Participants
|
|
Disease severity
Moderate Disease Severity
|
339 Participants
n=5 Participants
|
327 Participants
n=7 Participants
|
666 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The intent-to-treat (ITT) population includes all participants who were randomized
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Time to Recovery
|
7.0 Days
Interval 6.0 to 8.0
|
8.0 Days
Interval 7.0 to 9.0
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The intent-to-treat (ITT) population includes all participants who were randomized
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Time to Recovery by Race
Asian
|
10 Days
Interval 7.0 to 13.0
|
10.0 Days
Interval 9.0 to 13.0
|
|
Time to Recovery by Race
Black or African American
|
7.0 Days
Interval 5.0 to 8.0
|
6.0 Days
Interval 5.0 to 8.0
|
|
Time to Recovery by Race
White
|
7.0 Days
Interval 5.0 to 8.0
|
7.0 Days
Interval 6.0 to 9.0
|
|
Time to Recovery by Race
Other
|
7.0 Days
Interval 6.0 to 8.0
|
8.0 Days
Interval 6.0 to 11.0
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The intent-to-treat (ITT) population includes all participants who were randomized and for whom ethnicity was reported
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=509 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=508 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Time to Recovery by Ethnicity
Not Hispanic or Latino
|
7.0 Days
Interval 6.0 to 8.0
|
9.0 Days
Interval 7.0 to 10.0
|
|
Time to Recovery by Ethnicity
Hispanic or Latino
|
7.0 Days
Interval 6.0 to 8.0
|
7.0 Days
Interval 6.0 to 9.0
|
PRIMARY outcome
Timeframe: Day 1 through Day 29Population: The intent-to-treat (ITT) population includes all participants who were randomized
Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Time to Recovery by Sex
Male
|
7.0 Days
Interval 6.0 to 8.0
|
9.0 Days
Interval 7.0 to 11.0
|
|
Time to Recovery by Sex
Female
|
7.0 Days
Interval 6.0 to 8.0
|
7.0 Days
Interval 6.0 to 7.0
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=491 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=491 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Alanine Transaminase (ALT)
Day 3
|
3.3 Units/Liter (U/L)
Standard Deviation 37.1
|
2.0 Units/Liter (U/L)
Standard Deviation 30.1
|
|
Change From Baseline in Alanine Transaminase (ALT)
Day 5
|
16.8 Units/Liter (U/L)
Standard Deviation 104.4
|
8.8 Units/Liter (U/L)
Standard Deviation 40.9
|
|
Change From Baseline in Alanine Transaminase (ALT)
Day 8
|
7.9 Units/Liter (U/L)
Standard Deviation 45.2
|
7.8 Units/Liter (U/L)
Standard Deviation 46.9
|
|
Change From Baseline in Alanine Transaminase (ALT)
Day 11
|
0.0 Units/Liter (U/L)
Standard Deviation 37.5
|
7.3 Units/Liter (U/L)
Standard Deviation 70.2
|
|
Change From Baseline in Alanine Transaminase (ALT)
Day 15
|
5.0 Units/Liter (U/L)
Standard Deviation 61.5
|
3.9 Units/Liter (U/L)
Standard Deviation 55.1
|
|
Change From Baseline in Alanine Transaminase (ALT)
Day 29
|
-5.4 Units/Liter (U/L)
Standard Deviation 43.0
|
2.3 Units/Liter (U/L)
Standard Deviation 116.1
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=486 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=487 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 3
|
3.1 Units/Liter (U/L)
Standard Deviation 72.4
|
2.4 Units/Liter (U/L)
Standard Deviation 126.4
|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 5
|
27.4 Units/Liter (U/L)
Standard Deviation 413.1
|
2.8 Units/Liter (U/L)
Standard Deviation 48.3
|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 8
|
-5.6 Units/Liter (U/L)
Standard Deviation 38.4
|
-4.3 Units/Liter (U/L)
Standard Deviation 42.3
|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 11
|
-10.6 Units/Liter (U/L)
Standard Deviation 46.4
|
6.4 Units/Liter (U/L)
Standard Deviation 208.3
|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 15
|
-6.0 Units/Liter (U/L)
Standard Deviation 110.1
|
-3.9 Units/Liter (U/L)
Standard Deviation 91.0
|
|
Change From Baseline in Aspartate Transaminase (AST)
Day 29
|
-17.1 Units/Liter (U/L)
Standard Deviation 46.7
|
2.4 Units/Liter (U/L)
Standard Deviation 291.1
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=494 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=495 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Creatinine
Day 3
|
-0.036 milligrams/deciliter (mg/dL)
Standard Deviation 0.465
|
-0.019 milligrams/deciliter (mg/dL)
Standard Deviation 0.362
|
|
Change From Baseline in Creatinine
Day 5
|
-0.078 milligrams/deciliter (mg/dL)
Standard Deviation 0.475
|
0.001 milligrams/deciliter (mg/dL)
Standard Deviation 0.556
|
|
Change From Baseline in Creatinine
Day 8
|
-0.082 milligrams/deciliter (mg/dL)
Standard Deviation 0.570
|
0.129 milligrams/deciliter (mg/dL)
Standard Deviation 0.958
|
|
Change From Baseline in Creatinine
Day 11
|
-0.055 milligrams/deciliter (mg/dL)
Standard Deviation 0.798
|
0.194 milligrams/deciliter (mg/dL)
Standard Deviation 1.037
|
|
Change From Baseline in Creatinine
Day 15
|
-0.042 milligrams/deciliter (mg/dL)
Standard Deviation 0.714
|
0.094 milligrams/deciliter (mg/dL)
Standard Deviation 0.662
|
|
Change From Baseline in Creatinine
Day 29
|
-0.034 milligrams/deciliter (mg/dL)
Standard Deviation 0.678
|
0.033 milligrams/deciliter (mg/dL)
Standard Deviation 0.511
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=493 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=493 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Glucose
Day 3
|
-17.1 mg/dL
Standard Deviation 56.4
|
-6.0 mg/dL
Standard Deviation 54.0
|
|
Change From Baseline in Glucose
Day 5
|
-15.9 mg/dL
Standard Deviation 59.7
|
-1.6 mg/dL
Standard Deviation 58.4
|
|
Change From Baseline in Glucose
Day 8
|
-16.8 mg/dL
Standard Deviation 78.9
|
5.0 mg/dL
Standard Deviation 73.7
|
|
Change From Baseline in Glucose
Day 11
|
-8.1 mg/dL
Standard Deviation 72.3
|
1.2 mg/dL
Standard Deviation 66.2
|
|
Change From Baseline in Glucose
Day 15
|
-11.1 mg/dL
Standard Deviation 69.8
|
0.8 mg/dL
Standard Deviation 68.3
|
|
Change From Baseline in Glucose
Day 29
|
-4.6 mg/dL
Standard Deviation 66.5
|
-2.2 mg/dL
Standard Deviation 60.3
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=493 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=494 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Hemoglobin
Day 3
|
-0.46 grams/deciliter (g/dL)
Standard Deviation 1.05
|
-0.34 grams/deciliter (g/dL)
Standard Deviation 1.51
|
|
Change From Baseline in Hemoglobin
Day 5
|
-0.62 grams/deciliter (g/dL)
Standard Deviation 1.23
|
-0.64 grams/deciliter (g/dL)
Standard Deviation 1.13
|
|
Change From Baseline in Hemoglobin
Day 8
|
-0.93 grams/deciliter (g/dL)
Standard Deviation 1.61
|
-1.08 grams/deciliter (g/dL)
Standard Deviation 1.47
|
|
Change From Baseline in Hemoglobin
Day 11
|
-1.29 grams/deciliter (g/dL)
Standard Deviation 1.85
|
-1.62 grams/deciliter (g/dL)
Standard Deviation 1.88
|
|
Change From Baseline in Hemoglobin
Day 15
|
-0.96 grams/deciliter (g/dL)
Standard Deviation 1.87
|
-1.12 grams/deciliter (g/dL)
Standard Deviation 2.38
|
|
Change From Baseline in Hemoglobin
Day 29
|
-0.54 grams/deciliter (g/dL)
Standard Deviation 1.87
|
-0.77 grams/deciliter (g/dL)
Standard Deviation 2.25
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=493 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=494 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Platelets
Day 29
|
16.5 10^9 cells/liter
Standard Deviation 95.8
|
36.9 10^9 cells/liter
Standard Deviation 107.9
|
|
Change From Baseline in Platelets
Day 3
|
55.9 10^9 cells/liter
Standard Deviation 54.0
|
52.6 10^9 cells/liter
Standard Deviation 51.6
|
|
Change From Baseline in Platelets
Day 5
|
116.6 10^9 cells/liter
Standard Deviation 87.8
|
106.1 10^9 cells/liter
Standard Deviation 86.9
|
|
Change From Baseline in Platelets
Day 8
|
197.9 10^9 cells/liter
Standard Deviation 137.4
|
158.9 10^9 cells/liter
Standard Deviation 128.5
|
|
Change From Baseline in Platelets
Day 11
|
229.9 10^9 cells/liter
Standard Deviation 156.0
|
145.7 10^9 cells/liter
Standard Deviation 146.4
|
|
Change From Baseline in Platelets
Day 15
|
175.9 10^9 cells/liter
Standard Deviation 158.8
|
111.6 10^9 cells/liter
Standard Deviation 134.9
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=447 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=439 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 3
|
-0.03 ratio
Standard Deviation 1.13
|
0.05 ratio
Standard Deviation 0.59
|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 5
|
0.02 ratio
Standard Deviation 1.25
|
0.08 ratio
Standard Deviation 0.65
|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 8
|
0.01 ratio
Standard Deviation 0.96
|
0.08 ratio
Standard Deviation 0.98
|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 11
|
0.04 ratio
Standard Deviation 0.65
|
0.03 ratio
Standard Deviation 1.04
|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 15
|
-0.04 ratio
Standard Deviation 0.25
|
-0.08 ratio
Standard Deviation 0.91
|
|
Change From Baseline in Prothrombin International Normalized Ratio (INR)
Day 29
|
-0.12 ratio
Standard Deviation 0.55
|
-0.03 ratio
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=490 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=491 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Total Bilirubin
Day 3
|
-0.06 mg/dL
Standard Deviation 0.32
|
-0.01 mg/dL
Standard Deviation 0.43
|
|
Change From Baseline in Total Bilirubin
Day 5
|
-0.04 mg/dL
Standard Deviation 0.37
|
0.01 mg/dL
Standard Deviation 0.42
|
|
Change From Baseline in Total Bilirubin
Day 8
|
-0.06 mg/dL
Standard Deviation 0.41
|
0.01 mg/dL
Standard Deviation 0.66
|
|
Change From Baseline in Total Bilirubin
Day 11
|
-0.08 mg/dL
Standard Deviation 0.43
|
0.08 mg/dL
Standard Deviation 1.19
|
|
Change From Baseline in Total Bilirubin
Day 15
|
-0.10 mg/dL
Standard Deviation 0.37
|
0.08 mg/dL
Standard Deviation 1.20
|
|
Change From Baseline in Total Bilirubin
Day 29
|
-0.10 mg/dL
Standard Deviation 0.36
|
0.01 mg/dL
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=493 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=494 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 3
|
-0.831 10^9 cells/liter
Standard Deviation 3.020
|
-0.037 10^9 cells/liter
Standard Deviation 2.588
|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 5
|
-0.276 10^9 cells/liter
Standard Deviation 3.399
|
0.392 10^9 cells/liter
Standard Deviation 3.238
|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 8
|
0.663 10^9 cells/liter
Standard Deviation 4.006
|
1.606 10^9 cells/liter
Standard Deviation 4.536
|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 11
|
1.869 10^9 cells/liter
Standard Deviation 5.683
|
2.938 10^9 cells/liter
Standard Deviation 5.419
|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 15
|
0.694 10^9 cells/liter
Standard Deviation 5.125
|
2.162 10^9 cells/liter
Standard Deviation 5.741
|
|
Change From Baseline in White Blood Cell Count (WBC)
Day 29
|
-0.364 10^9 cells/liter
Standard Deviation 4.532
|
0.712 10^9 cells/liter
Standard Deviation 4.176
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
BBlood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=488 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=493 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Neutrophils
Day 3
|
-1.925 10^9 cells/liter
Standard Deviation 6.234
|
-0.333 10^9 cells/liter
Standard Deviation 2.787
|
|
Change From Baseline in Neutrophils
Day 5
|
-1.334 10^9 cells/liter
Standard Deviation 8.092
|
-0.204 10^9 cells/liter
Standard Deviation 3.630
|
|
Change From Baseline in Neutrophils
Day 8
|
-0.813 10^9 cells/liter
Standard Deviation 9.695
|
1.139 10^9 cells/liter
Standard Deviation 6.665
|
|
Change From Baseline in Neutrophils
Day 11
|
-0.046 10^9 cells/liter
Standard Deviation 8.881
|
1.847 10^9 cells/liter
Standard Deviation 5.152
|
|
Change From Baseline in Neutrophils
Day 15
|
-1.192 10^9 cells/liter
Standard Deviation 7.844
|
1.414 10^9 cells/liter
Standard Deviation 7.995
|
|
Change From Baseline in Neutrophils
Day 29
|
-1.708 10^9 cells/liter
Standard Deviation 6.735
|
-0.656 10^9 cells/liter
Standard Deviation 4.205
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=488 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=493 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Lymphocytes
Day 8
|
0.515 10^9 cells/liter
Standard Deviation 2.094
|
0.304 10^9 cells/liter
Standard Deviation 1.366
|
|
Change From Baseline in Lymphocytes
Day 11
|
0.541 10^9 cells/liter
Standard Deviation 1.204
|
0.409 10^9 cells/liter
Standard Deviation 0.709
|
|
Change From Baseline in Lymphocytes
Day 15
|
0.687 10^9 cells/liter
Standard Deviation 1.579
|
0.718 10^9 cells/liter
Standard Deviation 1.684
|
|
Change From Baseline in Lymphocytes
Day 29
|
0.653 10^9 cells/liter
Standard Deviation 1.293
|
0.927 10^9 cells/liter
Standard Deviation 1.996
|
|
Change From Baseline in Lymphocytes
Day 5
|
0.620 10^9 cells/liter
Standard Deviation 2.540
|
0.205 10^9 cells/liter
Standard Deviation 3.838
|
|
Change From Baseline in Lymphocytes
Day 3
|
0.503 10^9 cells/liter
Standard Deviation 2.290
|
0.074 10^9 cells/liter
Standard Deviation 3.844
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=487 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=493 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Monocytes
Day 3
|
0.004 10^9 cells/liter
Standard Deviation 0.810
|
0.062 10^9 cells/liter
Standard Deviation 0.750
|
|
Change From Baseline in Monocytes
Day 5
|
0.094 10^9 cells/liter
Standard Deviation 1.053
|
0.153 10^9 cells/liter
Standard Deviation 1.013
|
|
Change From Baseline in Monocytes
Day 8
|
0.105 10^9 cells/liter
Standard Deviation 0.948
|
0.279 10^9 cells/liter
Standard Deviation 0.758
|
|
Change From Baseline in Monocytes
Day 11
|
0.210 10^9 cells/liter
Standard Deviation 0.439
|
0.378 10^9 cells/liter
Standard Deviation 0.512
|
|
Change From Baseline in Monocytes
Day 15
|
0.256 10^9 cells/liter
Standard Deviation 0.591
|
0.329 10^9 cells/liter
Standard Deviation 0.606
|
|
Change From Baseline in Monocytes
Day 29
|
0.108 10^9 cells/liter
Standard Deviation 0.434
|
0.212 10^9 cells/liter
Standard Deviation 0.745
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=483 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=492 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Basophils
Day 5
|
0.007 10^9 cells/liter
Standard Deviation 0.070
|
0.006 10^9 cells/liter
Standard Deviation 0.044
|
|
Change From Baseline in Basophils
Day 8
|
0.011 10^9 cells/liter
Standard Deviation 0.055
|
0.017 10^9 cells/liter
Standard Deviation 0.075
|
|
Change From Baseline in Basophils
Day 11
|
0.014 10^9 cells/liter
Standard Deviation 0.063
|
0.022 10^9 cells/liter
Standard Deviation 0.063
|
|
Change From Baseline in Basophils
Day 15
|
0.026 10^9 cells/liter
Standard Deviation 0.085
|
0.037 10^9 cells/liter
Standard Deviation 0.104
|
|
Change From Baseline in Basophils
Day 29
|
0.022 10^9 cells/liter
Standard Deviation 0.045
|
0.036 10^9 cells/liter
Standard Deviation 0.092
|
|
Change From Baseline in Basophils
Day 3
|
0.000 10^9 cells/liter
Standard Deviation 0.039
|
0.001 10^9 cells/liter
Standard Deviation 0.050
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=484 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=492 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in Eosinophils
Day 3
|
0.050 10^9 cells/liter
Standard Deviation 0.135
|
0.039 10^9 cells/liter
Standard Deviation 0.201
|
|
Change From Baseline in Eosinophils
Day 5
|
0.104 10^9 cells/liter
Standard Deviation 0.402
|
0.075 10^9 cells/liter
Standard Deviation 0.257
|
|
Change From Baseline in Eosinophils
Day 8
|
0.088 10^9 cells/liter
Standard Deviation 0.126
|
0.086 10^9 cells/liter
Standard Deviation 0.232
|
|
Change From Baseline in Eosinophils
Day 11
|
0.078 10^9 cells/liter
Standard Deviation 0.119
|
0.115 10^9 cells/liter
Standard Deviation 0.299
|
|
Change From Baseline in Eosinophils
Day 15
|
0.121 10^9 cells/liter
Standard Deviation 0.231
|
0.109 10^9 cells/liter
Standard Deviation 0.163
|
|
Change From Baseline in Eosinophils
Day 29
|
0.192 10^9 cells/liter
Standard Deviation 0.171
|
0.205 10^9 cells/liter
Standard Deviation 0.267
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15, 22, and 29Population: The intent-to-treat (ITT) population includes all participants who were randomized with data at baseline and at each timepoint. Missing values were imputed using Last Observation Carried Forward.
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change in National Early Warning Score (NEWS) From Baseline
Day 3
|
-0.5 units on a scale
Standard Deviation 2.5
|
-0.1 units on a scale
Standard Deviation 2.6
|
|
Change in National Early Warning Score (NEWS) From Baseline
Day 5
|
-0.9 units on a scale
Standard Deviation 2.8
|
-0.4 units on a scale
Standard Deviation 2.8
|
|
Change in National Early Warning Score (NEWS) From Baseline
Day 8
|
-1.5 units on a scale
Standard Deviation 2.9
|
-0.8 units on a scale
Standard Deviation 3.3
|
|
Change in National Early Warning Score (NEWS) From Baseline
Day 11
|
-1.8 units on a scale
Standard Deviation 3.2
|
-1.1 units on a scale
Standard Deviation 3.5
|
|
Change in National Early Warning Score (NEWS) From Baseline
Day 15
|
-2.1 units on a scale
Standard Deviation 3.3
|
-1.2 units on a scale
Standard Deviation 3.9
|
|
Change in National Early Warning Score (NEWS) From Baseline
Day 22
|
-2.0 units on a scale
Standard Deviation 3.8
|
-1.2 units on a scale
Standard Deviation 4.6
|
|
Change in National Early Warning Score (NEWS) From Baseline
Day 29
|
-2.2 units on a scale
Standard Deviation 4.3
|
-1.4 units on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The safety population includes all participants with available data post baseline, analyzed as treated.
Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=507 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=509 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs)
|
40.8 percentage of participants
Interval 36.5 to 45.3
|
46.8 percentage of participants
Interval 42.4 to 51.2
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The safety population includes all participants with available data post baseline, analyzed as treated.
An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=507 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=509 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants Reporting Serious Adverse Events (SAEs)
|
16.0 percentage of participants
Interval 12.9 to 19.5
|
21.0 percentage of participants
Interval 17.6 to 24.8
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The intent-to-treat (ITT) population includes all participants who were randomized
Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Duration of Hospitalization
Including imputation for participants who died
|
8 Days
Interval 5.0 to 15.0
|
8 Days
Interval 5.0 to 20.0
|
|
Duration of Hospitalization
Restricted to participants who did not die
|
8 Days
Interval 5.0 to 13.0
|
8 Days
Interval 5.0 to 15.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The analysis population is restricted to randomized participants who were not on non-invasive ventilation or high-flow oxygen at baseline but who subsequently required non-invasive or high-flow oxygen.
Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=70 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=82 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Duration of New Non-invasive Ventilation or High Flow Oxygen Use
Including imputations for participants who died
|
6 Days
Interval 3.0 to 15.0
|
4.5 Days
Interval 2.0 to 11.0
|
|
Duration of New Non-invasive Ventilation or High Flow Oxygen Use
Among participants who did not die
|
5 Days
Interval 3.0 to 10.0
|
4 Days
Interval 2.0 to 7.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The analysis population is restricted to randomized participants who were not on oxygen at baseline but who subsequently required oxygen.
Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=16 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=29 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Duration of New Oxygen Use
Among participants who did not die
|
3 Days
Interval 2.0 to 4.0
|
3 Days
Interval 2.0 to 6.0
|
|
Duration of New Oxygen Use
Including imputations for participants who died
|
3 Days
Interval 2.0 to 4.0
|
3 Days
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline but who subsequently required a ventilator or ECMO.
Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=46 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=70 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Including imputations for participants who died
|
16 Days
Interval 8.0 to 28.0
|
27 Days
Interval 12.0 to 28.0
|
|
Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Among participants who did not die
|
13 Days
Interval 6.0 to 22.0
|
20 Days
Interval 10.0 to 27.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The analysis population is restricted to randomized participants who were on oxygen at baseline.
Duration of oxygen use was measured in days among participants who were on oxygen in based, calculated in two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=445 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=446 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Duration of Oxygen Use
Including imputations for participants who died
|
10 Days
Interval 4.0 to 27.0
|
12 Days
Interval 4.0 to 28.0
|
|
Duration of Oxygen Use
Among participants who did not die
|
9 Days
Interval 4.0 to 24.0
|
10 Days
Interval 4.0 to 28.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 14Population: The intent-to-treat (ITT) population includes all participants who were randomized
Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses of Remdesivir, or in the 14 doses of Baricitinib/placebo.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Received less than 10 Infusions of Remdesivir due to Discharge
|
55 percentage of participants
Interval 50.0 to 59.0
|
51 percentage of participants
Interval 47.0 to 55.0
|
|
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Received less than 10 Infusions of Remdesivir due to Death
|
0 percentage of participants
Interval 0.0 to 1.0
|
1 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Received less than 14 doses of Baricitinib/Placebo due to Discharge
|
66 percentage of participants
Interval 62.0 to 70.0
|
59 percentage of participants
Interval 55.0 to 64.0
|
|
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Received less than 14 doses of Baricitinib/Placebo due to Death
|
0 percentage of participants
Interval 0.0 to 1.0
|
1 percentage of participants
Interval 1.0 to 3.0
|
|
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Had Any Infusions of Remdesivir Halted or Slowed
|
2 percentage of participants
Interval 1.0 to 4.0
|
2 percentage of participants
Interval 1.0 to 3.0
|
|
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Had Any Oral Doses of Baricitinib/Placebo Modified
|
16 percentage of participants
Interval 13.0 to 20.0
|
18 percentage of participants
Interval 14.0 to 21.0
|
|
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Missed Any Maintenance Dose of Remdesivir
|
23 percentage of participants
Interval 20.0 to 27.0
|
27 percentage of participants
Interval 23.0 to 31.0
|
|
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Missed Any Oral Dose of Baricitinib/Placebo
|
30 percentage of participants
Interval 26.0 to 34.0
|
34 percentage of participants
Interval 30.0 to 38.0
|
|
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Terminated Early Prior to Completing 10 Infusions of Remdesivir
|
3 percentage of participants
Interval 2.0 to 5.0
|
4 percentage of participants
Interval 3.0 to 6.0
|
|
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics
Terminated Early Prior to Completing 14 doses of Baricitinib/Placebo
|
4 percentage of participants
Interval 2.0 to 6.0
|
5 percentage of participants
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The analysis population is restricted to randomized participants not on a ventilator or ECMO at baseline.
The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=461 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=461 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
|
10 percentage of participants
Interval 8.0 to 13.0
|
15 percentage of participants
Interval 12.0 to 19.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The analysis population is restricted to randomized participants not requiring oxygen at baseline.
The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=70 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=72 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants Requiring New Oxygen Use
|
23 percentage of participants
Interval 15.0 to 34.0
|
40 percentage of participants
Interval 30.0 to 52.0
|
SECONDARY outcome
Timeframe: Day 1, 3, 5, 8, 11, 15, 22, and 29Population: The intent-to-treat (ITT) population includes all participants who were randomized reporting a clinical score. Missing values were imputed using Last Observation Carried Forward.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Mean Change in the Ordinal Scale
Day 3
|
0.1 units on a scale
Standard Deviation 0.5
|
0.1 units on a scale
Standard Deviation 0.6
|
|
Mean Change in the Ordinal Scale
Day 5
|
0.0 units on a scale
Standard Deviation 0.7
|
0.0 units on a scale
Standard Deviation 0.7
|
|
Mean Change in the Ordinal Scale
Day 8
|
-0.3 units on a scale
Standard Deviation 0.9
|
-0.1 units on a scale
Standard Deviation 0.9
|
|
Mean Change in the Ordinal Scale
Day 11
|
-0.4 units on a scale
Standard Deviation 1.0
|
-0.2 units on a scale
Standard Deviation 1.0
|
|
Mean Change in the Ordinal Scale
Day 15
|
-2.3 units on a scale
Standard Deviation 1.9
|
-1.9 units on a scale
Standard Deviation 2.0
|
|
Mean Change in the Ordinal Scale
Day 22
|
-2.7 units on a scale
Standard Deviation 1.9
|
-2.3 units on a scale
Standard Deviation 2.1
|
|
Mean Change in the Ordinal Scale
Day 29
|
-2.9 units on a scale
Standard Deviation 1.9
|
-2.5 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Day 15Population: The intent-to-treat (ITT) population includes all participants who were randomized.
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Data was imputed using last observation carried forward or worst possible score based on hospitalization status (2 if not hospitalized, 7 if hospitalized) when there was a change in hospitalization status since last score. Deaths were imputed as an 8.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Death at or before study visit
|
2 percentage of participants
Interval 1.0 to 4.0
|
3 percentage of participants
Interval 2.0 to 5.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Hospitalized, on invasive mech. vent. or ECMO
|
9 percentage of participants
Interval 7.0 to 12.0
|
16 percentage of participants
Interval 13.0 to 19.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Hospitalized, on non-invasive vent./high flow O2
|
4 percentage of participants
Interval 3.0 to 6.0
|
4 percentage of participants
Interval 2.0 to 6.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Hospitalized, requiring supplemental oxygen
|
8 percentage of participants
Interval 6.0 to 11.0
|
10 percentage of participants
Interval 7.0 to 13.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Hospitalized, not on O2, requiring ongoing care
|
6 percentage of participants
Interval 4.0 to 8.0
|
3 percentage of participants
Interval 2.0 to 5.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Hospitalized, not requiring O2, no longer req care
|
2 percentage of participants
Interval 1.0 to 3.0
|
1 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Not hospitalized, limit on activities/req home O2
|
34 percentage of participants
Interval 30.0 to 39.0
|
31 percentage of participants
Interval 28.0 to 36.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15
Not hospitalized, no limitations on activities
|
34 percentage of participants
Interval 30.0 to 39.0
|
32 percentage of participants
Interval 28.0 to 36.0
|
SECONDARY outcome
Timeframe: Day 1Population: The intent-to-treat (ITT) population includes all participants who were randomized
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
Death at or before study Visit
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
Hospitalized, on invasive mech. vent. or ECMO
|
10 percentage of participants
Interval 8.0 to 13.0
|
11 percentage of participants
Interval 9.0 to 14.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
Hospitalized, on non-invasive vent./high flow O2
|
20 percentage of participants
Interval 17.0 to 24.0
|
22 percentage of participants
Interval 18.0 to 26.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
Hospitalized, requiring supplemental oxygen
|
56 percentage of participants
Interval 52.0 to 60.0
|
53 percentage of participants
Interval 49.0 to 58.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
Hospitalized, not on O2, requiring ongoing care
|
14 percentage of participants
Interval 11.0 to 17.0
|
14 percentage of participants
Interval 11.0 to 17.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
Hospitalized, not requiring O2, no longer req care
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
Not hospitalized, limit on activities/req home O2
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
Not hospitalized, no limitations on activities
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
No clinical status score reported - Hospitalized
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
No clinical status score reported - Discharged
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1
No clinical status score reported - Discontinued
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Day 3Population: The intent-to-treat (ITT) population includes all participants who were randomized
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
Death at or before study Visit
|
0.4 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
Hospitalized, on invasive mech. vent. or ECMO
|
15 percentage of participants
Interval 12.0 to 18.0
|
16 percentage of participants
Interval 13.0 to 20.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
Hospitalized, on non-invasive vent./high flow O2
|
22 percentage of participants
Interval 18.0 to 25.0
|
22 percentage of participants
Interval 18.0 to 25.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
Hospitalized, requiring supplemental oxygen
|
45 percentage of participants
Interval 41.0 to 50.0
|
44 percentage of participants
Interval 40.0 to 49.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
Hospitalized, not on O2, requiring ongoing care
|
16 percentage of participants
Interval 13.0 to 20.0
|
14 percentage of participants
Interval 12.0 to 18.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
Hospitalized, not requiring O2, no longer req care
|
0.2 percentage of participants
Interval 0.0 to 1.0
|
1 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
Not hospitalized, limit on activities/req home O2
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
Not hospitalized, no limitations on activities
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
No clinical status score reported - Hospitalized
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
No clinical status score reported - Discharged
|
0.2 percentage of participants
Interval 0.0 to 1.0
|
0.4 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3
No clinical status score reported - Discontinued
|
1 percentage of participants
Interval 1.0 to 3.0
|
2 percentage of participants
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 5Population: The intent-to-treat (ITT) population includes all participants who were randomized
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
Death at or before study Visit
|
1 percentage of participants
Interval 0.0 to 2.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
Hospitalized, on invasive mech. vent. or ECMO
|
15 percentage of participants
Interval 12.0 to 19.0
|
18 percentage of participants
Interval 15.0 to 21.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
Hospitalized, on non-invasive vent./high flow O2
|
17 percentage of participants
Interval 14.0 to 20.0
|
18 percentage of participants
Interval 15.0 to 22.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
Hospitalized, requiring supplemental oxygen
|
35 percentage of participants
Interval 31.0 to 39.0
|
33 percentage of participants
Interval 29.0 to 37.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
Hospitalized, not on O2, requiring ongoing care
|
19 percentage of participants
Interval 16.0 to 22.0
|
15 percentage of participants
Interval 12.0 to 18.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
Hospitalized, not requiring O2, no longer req care
|
1 percentage of participants
Interval 0.0 to 2.0
|
1 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
Not hospitalized, limit on activities/req home O2
|
0.2 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
Not hospitalized, no limitations on activities
|
0.2 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
No clinical status score reported - Hospitalized
|
0 percentage of participants
Interval 0.0 to 1.0
|
0.2 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
No clinical status score reported - Discharged
|
10 percentage of participants
Interval 8.0 to 13.0
|
13 percentage of participants
Interval 10.0 to 16.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5
No clinical status score reported - Discontinued
|
2 percentage of participants
Interval 1.0 to 4.0
|
3 percentage of participants
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 8Population: The intent-to-treat (ITT) population includes all participants who were randomized
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
Death at or before study Visit
|
1 percentage of participants
Interval 0.0 to 2.0
|
1 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
Hospitalized, on invasive mech. vent. or ECMO
|
13 percentage of participants
Interval 11.0 to 17.0
|
18 percentage of participants
Interval 15.0 to 22.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
Hospitalized, on non-invasive vent./high flow O2
|
11 percentage of participants
Interval 8.0 to 14.0
|
12 percentage of participants
Interval 9.0 to 15.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
Hospitalized, requiring supplemental oxygen
|
18 percentage of participants
Interval 15.0 to 22.0
|
18 percentage of participants
Interval 15.0 to 22.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
Hospitalized, not on O2, requiring ongoing care
|
12 percentage of participants
Interval 10.0 to 16.0
|
10 percentage of participants
Interval 7.0 to 13.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
Hospitalized, not requiring O2, no longer req care
|
1 percentage of participants
Interval 0.0 to 2.0
|
1 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
Not hospitalized, limit on activities/req home O2
|
0.2 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
Not hospitalized, no limitations on activities
|
0.4 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
No clinical status score reported - Hospitalized
|
0 percentage of participants
Interval 0.0 to 1.0
|
0.4 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
No clinical status score reported - Discharged
|
40 percentage of participants
Interval 35.0 to 44.0
|
36 percentage of participants
Interval 32.0 to 41.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8
No clinical status score reported - Discontinued
|
3 percentage of participants
Interval 2.0 to 5.0
|
4 percentage of participants
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: Day 11Population: The intent-to-treat (ITT) population includes all participants who were randomized
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
Death at or before study Visit
|
1 percentage of participants
Interval 0.0 to 2.0
|
2 percentage of participants
Interval 1.0 to 4.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
Hospitalized, on invasive mech. vent. or ECMO
|
11 percentage of participants
Interval 9.0 to 14.0
|
16 percentage of participants
Interval 13.0 to 20.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
Hospitalized, on non-invasive vent./high flow O2
|
6 percentage of participants
Interval 5.0 to 9.0
|
7 percentage of participants
Interval 5.0 to 9.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
Hospitalized, requiring supplemental oxygen
|
12 percentage of participants
Interval 10.0 to 15.0
|
10 percentage of participants
Interval 8.0 to 13.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
Hospitalized, not on O2, requiring ongoing care
|
9 percentage of participants
Interval 6.0 to 11.0
|
7 percentage of participants
Interval 5.0 to 9.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
Hospitalized, not requiring O2, no longer req care
|
1 percentage of participants
Interval 0.0 to 2.0
|
1 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
Not hospitalized, limit on activities/req home O2
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
Not hospitalized, no limitations on activities
|
0.2 percentage of participants
Interval 0.0 to 1.0
|
0.2 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
No clinical status score reported - Hospitalized
|
0 percentage of participants
Interval 0.0 to 1.0
|
1 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
No clinical status score reported - Discharged
|
56 percentage of participants
Interval 52.0 to 60.0
|
52 percentage of participants
Interval 48.0 to 56.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11
No clinical status score reported - Discontinued
|
3 percentage of participants
Interval 2.0 to 5.0
|
4 percentage of participants
Interval 3.0 to 6.0
|
SECONDARY outcome
Timeframe: Day 22Population: The intent-to-treat (ITT) population includes all participants who were randomized
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
Death at or before study Visit
|
4 percentage of participants
Interval 3.0 to 6.0
|
6 percentage of participants
Interval 5.0 to 9.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
Hospitalized, on invasive mech. vent. or ECMO
|
6 percentage of participants
Interval 4.0 to 8.0
|
9 percentage of participants
Interval 7.0 to 12.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
Hospitalized, on non-invasive vent./high flow O2
|
3 percentage of participants
Interval 2.0 to 5.0
|
1 percentage of participants
Interval 1.0 to 3.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
Hospitalized, requiring supplemental oxygen
|
3 percentage of participants
Interval 2.0 to 5.0
|
5 percentage of participants
Interval 3.0 to 7.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
Hospitalized, not on O2, requiring ongoing care
|
2 percentage of participants
Interval 1.0 to 4.0
|
3 percentage of participants
Interval 1.0 to 4.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
Hospitalized, not requiring O2, no longer req care
|
1 percentage of participants
Interval 1.0 to 3.0
|
0.4 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
Not hospitalized, limit on activities/req home O2
|
24 percentage of participants
Interval 21.0 to 28.0
|
25 percentage of participants
Interval 21.0 to 29.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
Not hospitalized, no limitations on activities
|
44 percentage of participants
Interval 40.0 to 49.0
|
37 percentage of participants
Interval 33.0 to 42.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
No clinical status score reported - Hospitalized
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
No clinical status score reported - Discharged
|
4 percentage of participants
Interval 2.0 to 6.0
|
3 percentage of participants
Interval 2.0 to 5.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22
No clinical status score reported - Discontinued
|
9 percentage of participants
Interval 6.0 to 11.0
|
10 percentage of participants
Interval 8.0 to 13.0
|
SECONDARY outcome
Timeframe: Day 29Population: The intent-to-treat (ITT) population includes all participants who were randomized
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
Death at or before study Visit
|
5 percentage of participants
Interval 3.0 to 7.0
|
7 percentage of participants
Interval 5.0 to 10.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
Hospitalized, on invasive mech. vent. or ECMO
|
3 percentage of participants
Interval 2.0 to 5.0
|
7 percentage of participants
Interval 5.0 to 9.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
Hospitalized, on non-invasive vent./high flow O2
|
2 percentage of participants
Interval 1.0 to 3.0
|
1 percentage of participants
Interval 1.0 to 3.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
Hospitalized, requiring supplemental oxygen
|
2 percentage of participants
Interval 1.0 to 4.0
|
3 percentage of participants
Interval 2.0 to 5.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
Hospitalized, not on O2, requiring ongoing care
|
3 percentage of participants
Interval 2.0 to 5.0
|
1 percentage of participants
Interval 0.0 to 2.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
Hospitalized, not requiring O2, no longer req care
|
1 percentage of participants
Interval 0.0 to 2.0
|
0.2 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
Not hospitalized, limit on activities/req home O2
|
23 percentage of participants
Interval 20.0 to 27.0
|
23 percentage of participants
Interval 20.0 to 27.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
Not hospitalized, no limitations on activities
|
49 percentage of participants
Interval 44.0 to 53.0
|
43 percentage of participants
Interval 39.0 to 47.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
No clinical status score reported - Hospitalized
|
0 percentage of participants
Interval 0.0 to 1.0
|
0 percentage of participants
Interval 0.0 to 1.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
No clinical status score reported - Discharged
|
0.4 percentage of participants
Interval 0.0 to 1.0
|
1 percentage of participants
Interval 1.0 to 3.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
No clinical status score reported - Discontinued
|
12 percentage of participants
Interval 9.0 to 15.0
|
13 percentage of participants
Interval 10.0 to 16.0
|
|
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29
No clinical status, completed study without reporting score
|
0.2 percentage of participants
Interval 0.0 to 1.0
|
0.2 percentage of participants
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 15Population: The ITT population consists of all participants as randomized.
The mortality rate was determined as the proportion of participants who died by study Day 15. The proportions reported are Kaplan-Meier estimates.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
14-day Participant Mortality
|
0.02 proportion of participants
Interval 0.01 to 0.03
|
0.03 proportion of participants
Interval 0.02 to 0.05
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The ITT population includes all participants as randomized.
The mortality rate was determined as the proportion of participants who died by study Day 29. The proportions reported are Kaplan-Meier estimates.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
28-day Participant Mortality
|
0.05 proportion of participants
Interval 0.03 to 0.08
|
0.08 proportion of participants
Interval 0.06 to 0.11
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The ITT population includes all participants as randomized
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Time to an Improvement of One Category Using an Ordinal Scale
|
6.0 Days
Interval 5.0 to 7.0
|
8.0 Days
Interval 7.0 to 9.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The ITT population includes all participants as randomized
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Time to improvement by at least two categories was determined for each participant
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=515 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=518 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Time to an Improvement of Two Categories Using an Ordinal Scale
|
12.0 Days
Interval 12.0 to 13.0
|
13.0 Days
Due to a large number of subjects improving 13 days post randomization there is little variability at the 50th percentile and the methodology described by Klein and Moeschberger (1997) is unable to compute a confidence interval
|
SECONDARY outcome
Timeframe: Day 1 through Day 29Population: The ITT population includes participants as randomized, and restricted to those with a baseline NEWS score of 2 or greater.
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=361 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=334 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First
|
6.0 Days
Interval 6.0 to 7.0
|
7.0 Days
Interval 6.0 to 9.0
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=446 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=455 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in C-reactive Protein (CRP)
Day 3
|
-23.035 mg/L
Standard Deviation 169.442
|
-18.671 mg/L
Standard Deviation 102.661
|
|
Change From Baseline in C-reactive Protein (CRP)
Day 5
|
-58.935 mg/L
Standard Deviation 110.364
|
-30.908 mg/L
Standard Deviation 150.076
|
|
Change From Baseline in C-reactive Protein (CRP)
Day 8
|
-78.411 mg/L
Standard Deviation 104.943
|
-62.038 mg/L
Standard Deviation 125.254
|
|
Change From Baseline in C-reactive Protein (CRP)
Day 11
|
-103.789 mg/L
Standard Deviation 124.751
|
-88.881 mg/L
Standard Deviation 159.184
|
|
Change From Baseline in C-reactive Protein (CRP)
Day 15
|
-122.339 mg/L
Standard Deviation 110.502
|
-112.588 mg/L
Standard Deviation 155.762
|
|
Change From Baseline in C-reactive Protein (CRP)
Day 29
|
-131.333 mg/L
Standard Deviation 115.243
|
-122.342 mg/L
Standard Deviation 268.733
|
SECONDARY outcome
Timeframe: Days 1, 3, 5, 8, 11, 15 and 29Population: The safety population includes all treated participants with available data at baseline and the post baseline assessment point, analyzed as treated.
Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Outcome measures
| Measure |
Remdesivir Plus Baricitinib
n=436 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=432 Participants
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Change From Baseline in D-dimer Concentration
Day 3
|
-0.374 mg/L
Standard Deviation 7.062
|
0.384 mg/L
Standard Deviation 5.663
|
|
Change From Baseline in D-dimer Concentration
Day 5
|
0.053 mg/L
Standard Deviation 10.968
|
-0.149 mg/L
Standard Deviation 5.978
|
|
Change From Baseline in D-dimer Concentration
Day 8
|
-0.271 mg/L
Standard Deviation 9.994
|
0.351 mg/L
Standard Deviation 5.387
|
|
Change From Baseline in D-dimer Concentration
Day 11
|
0.622 mg/L
Standard Deviation 12.779
|
0.309 mg/L
Standard Deviation 7.283
|
|
Change From Baseline in D-dimer Concentration
Day 15
|
-0.988 mg/L
Standard Deviation 11.352
|
-0.422 mg/L
Standard Deviation 6.579
|
|
Change From Baseline in D-dimer Concentration
Day 29
|
0.774 mg/L
Standard Deviation 27.229
|
-0.219 mg/L
Standard Deviation 10.386
|
Adverse Events
Remdesivir Plus Baricitinib
Serious events: 88 serious events
Other events: 147 other events
Deaths: 24 deaths
Remdesivir Plus Placebo
Serious events: 109 serious events
Other events: 164 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
Remdesivir Plus Baricitinib
n=507 participants at risk
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=509 participants at risk
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.7%
29/507 • Number of events 30 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
7.3%
37/509 • Number of events 38 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.6%
18/507 • Number of events 18 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
3.1%
16/509 • Number of events 16 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.99%
5/507 • Number of events 5 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
2.2%
11/509 • Number of events 11 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.79%
4/507 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
2.0%
10/509 • Number of events 10 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Septic shock
|
0.79%
4/507 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
1.6%
8/509 • Number of events 8 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Vascular disorders
Hypotension
|
1.2%
6/507 • Number of events 6 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.98%
5/509 • Number of events 5 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.4%
7/507 • Number of events 8 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
1.4%
7/509 • Number of events 7 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Pneumonia
|
0.39%
2/507 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
1.6%
8/509 • Number of events 8 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.39%
2/507 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
1.2%
6/509 • Number of events 6 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.99%
5/507 • Number of events 5 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.59%
3/507 • Number of events 3 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.59%
3/509 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Vascular disorders
Shock
|
0.39%
2/507 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.79%
4/509 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Cardiac arrest
|
0.39%
2/507 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.59%
3/509 • Number of events 3 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.39%
2/507 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.79%
4/509 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.79%
4/509 • Number of events 4 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Sepsis
|
0.39%
2/507 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.98%
5/509 • Number of events 5 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.98%
5/509 • Number of events 5 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.39%
2/507 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.39%
2/509 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.39%
2/509 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Encephalopathy
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.39%
2/509 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.59%
3/509 • Number of events 3 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
General disorders
Chest pain
|
0.39%
2/507 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.39%
2/509 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
General disorders
Asthenia
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Cardiac failure
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Vascular disorders
Distributive shock
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Intervertebral discitis
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Lymphocyte count decreased
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Nervous system disorder
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
General disorders
Non-cardiac chest pain
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Prostatic abscess
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Sinus tachycardia
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Vascular disorders
Thrombophlebitis
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Eye disorders
Visual impairment
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Hepatobiliary disorders
Hepatic haemorrhage
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
General disorders
Injection site induration
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.39%
2/509 • Number of events 2 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Troponin increased
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/507 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.20%
1/509 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.20%
1/507 • Number of events 1 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
0.00%
0/509 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
Other adverse events
| Measure |
Remdesivir Plus Baricitinib
n=507 participants at risk
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
Remdesivir Plus Placebo
n=509 participants at risk
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10-day total course and 4 mg (2 tablets of 2 mg) of Baricitinib Placebo administered orally daily for the duration of the hospitalization up to a 14-day total course.
|
|---|---|---|
|
Investigations
Glomerular filtration rate decreased
|
9.9%
50/507 • Number of events 52 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
8.8%
45/509 • Number of events 46 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.7%
29/507 • Number of events 34 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
7.9%
40/509 • Number of events 47 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Haemoglobin decreased
|
5.9%
30/507 • Number of events 32 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
6.1%
31/509 • Number of events 32 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Lymphocyte count decreased
|
4.9%
25/507 • Number of events 28 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
7.1%
36/509 • Number of events 36 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.9%
25/507 • Number of events 28 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
6.1%
31/509 • Number of events 40 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Investigations
Blood glucose increased
|
5.1%
26/507 • Number of events 26 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
5.5%
28/509 • Number of events 28 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
16/507 • Number of events 17 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
5.3%
27/509 • Number of events 28 • Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.
Given the severity of underlying illness, participants were expected to have many symptoms and abnormalities in vital signs and laboratory values. All Grade 3 and 4 AEs were captured as AEs in this trial. Grade 2 or higher, suspected drug-related hypersensitivity reaction or deep vein thrombosis of any grade was reported as an AE in this trial. All cause mortality was calculated for the ITT population, while SAEs and AEs reflect the as treated population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60