Trial Outcomes & Findings for A Study of Baricitinib (LY3009104) in Participants With COVID-19 (NCT NCT04421027)
NCT ID: NCT04421027
Last Updated: 2022-07-28
Results Overview
Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1525 participants
Primary outcome timeframe
Day 1 to Day 28
Results posted on
2022-07-28
Participant Flow
Participant milestones
| Measure |
Placebo + Standard of Care (SOC)
Placebo tablets administered orally every day (QD) with standard of care.
|
Baricitinib + SOC
4 milligrams (mg) baricitinib administered orally QD with standard of care.
|
Placebo + SOC Follow-Up
Participants did not receive drug during the Follow-Up Period.
|
Baricitinib + SOC Follow-Up
Participants did not receive drug during the Follow-Up Period.
|
|---|---|---|---|---|
|
Treatment Period
STARTED
|
761
|
764
|
0
|
0
|
|
Treatment Period
Received at Least One Dose of Study Drug
|
752
|
750
|
0
|
0
|
|
Treatment Period
COMPLETED
|
604
|
644
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
157
|
120
|
0
|
0
|
|
Follow-Up Period
STARTED
|
0
|
0
|
613
|
645
|
|
Follow-Up Period
COMPLETED
|
0
|
0
|
588
|
615
|
|
Follow-Up Period
NOT COMPLETED
|
0
|
0
|
25
|
30
|
Reasons for withdrawal
| Measure |
Placebo + Standard of Care (SOC)
Placebo tablets administered orally every day (QD) with standard of care.
|
Baricitinib + SOC
4 milligrams (mg) baricitinib administered orally QD with standard of care.
|
Placebo + SOC Follow-Up
Participants did not receive drug during the Follow-Up Period.
|
Baricitinib + SOC Follow-Up
Participants did not receive drug during the Follow-Up Period.
|
|---|---|---|---|---|
|
Treatment Period
Adverse Event
|
5
|
3
|
0
|
0
|
|
Treatment Period
Death
|
98
|
61
|
0
|
0
|
|
Treatment Period
Lost to Follow-up
|
22
|
20
|
0
|
0
|
|
Treatment Period
Other-Unknown
|
15
|
9
|
0
|
0
|
|
Treatment Period
Physician Decision
|
1
|
1
|
0
|
0
|
|
Treatment Period
Withdrawal by Subject
|
7
|
12
|
0
|
0
|
|
Treatment Period
Randomized Not Dosed
|
9
|
14
|
0
|
0
|
|
Follow-Up Period
Adverse Event
|
0
|
0
|
0
|
3
|
|
Follow-Up Period
Death
|
0
|
0
|
16
|
17
|
|
Follow-Up Period
Lost to Follow-up
|
0
|
0
|
7
|
7
|
|
Follow-Up Period
Protocol Deviation
|
0
|
0
|
1
|
0
|
|
Follow-Up Period
Still in hospital on ventilator at end of study
|
0
|
0
|
1
|
0
|
|
Follow-Up Period
Left message, participant did not call back
|
0
|
0
|
0
|
1
|
|
Follow-Up Period
Participant died
|
0
|
0
|
0
|
1
|
|
Follow-Up Period
Participant was alive but did not respond to calls
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Baricitinib (LY3009104) in Participants With COVID-19
Baseline characteristics by cohort
| Measure |
Placebo +SOC
n=761 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=764 Participants
4 mg baricitinib administered orally QD with standard of care.
|
Total
n=1525 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 13.8 • n=99 Participants
|
57.8 years
STANDARD_DEVIATION 14.3 • n=107 Participants
|
57.6 years
STANDARD_DEVIATION 14.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
288 Participants
n=99 Participants
|
274 Participants
n=107 Participants
|
562 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
473 Participants
n=99 Participants
|
490 Participants
n=107 Participants
|
963 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
168 Participants
n=99 Participants
|
148 Participants
n=107 Participants
|
316 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
94 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
174 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
440 Participants
n=99 Participants
|
480 Participants
n=107 Participants
|
920 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Region of Enrollment
Puerto Rico
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
Argentina
|
101 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
208 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
155 Participants
n=99 Participants
|
154 Participants
n=107 Participants
|
309 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
19 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
India
|
31 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
54 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
42 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
20 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
165 Participants
n=99 Participants
|
172 Participants
n=107 Participants
|
337 Participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
143 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
281 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.
Percentage of participants who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO).
Outcome measures
| Measure |
Placebo + SOC
n=756 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=762 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO])
|
30.5 percentage of participants
Interval 27.2 to 33.8
|
27.8 percentage of participants
Interval 24.6 to 31.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention who at baseline required oxygen supplementation and did not receive dexamethasone, or other systemic corticosteroids for the primary study condition.
Percentage of participants who die or require non-invasive ventilation or invasive mechanical ventilation, including ECMO.
Outcome measures
| Measure |
Placebo + SOC
n=109 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=96 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Percentage of Participants Who Die or Require Non-Invasive Ventilation/High-Flow Oxygen or Invasive Mechanical Ventilation (Including Extracorporeal Membrane Oxygenation [ECMO] Population 2
|
27.1 percentage of participants
Interval 18.7 to 35.6
|
28.9 percentage of participants
Interval 19.6 to 38.2
|
SECONDARY outcome
Timeframe: Day 10Population: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.
The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. Participants with missing baseline ordinal scale values were excluded from analysis.
Outcome measures
| Measure |
Placebo + SOC
n=756 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=762 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Percentage of Participants With at Least 1-Point Improvement on National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) or Live Discharge From Hospital
|
63.5 percentage of participants
Interval 60.1 to 67.0
|
65.0 percentage of participants
Interval 61.6 to 68.5
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded.
Number of days free of invasive mechanical ventilation.
Outcome measures
| Measure |
Placebo + SOC
n=756 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=762 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Number of Ventilator-Free Days
|
23.7 days
Standard Error 0.39
|
24.5 days
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention.
Recovery assessed by the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS). Time to reach NIAID-OS 1, 2, or 3 for the first time. The date reached is the first full day that OS 1, 2, or 3 is the participant's maximum OS for the day. NIAID-OS 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities and/or requiring home oxygen 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.)
Outcome measures
| Measure |
Placebo + SOC
n=761 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=764 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Time to Recovery
|
11.0 days
Interval 10.0 to 12.0
|
10.0 days
Interval 9.0 to 11.0
|
SECONDARY outcome
Timeframe: Day 4Population: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.
Overall improvement on the National Institute of Allergy and Infectious Diseases 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 - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
Outcome measures
| Measure |
Placebo + SOC
n=756 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=762 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
Day 4 NIAID-OS 1
|
4.6 percentage of participants
Interval 3.1 to 6.1
|
5.2 percentage of participants
Interval 3.6 to 6.8
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
Day 4 NIAID-OS 4
|
19.4 percentage of participants
Interval 16.6 to 22.3
|
23.6 percentage of participants
Interval 20.6 to 26.7
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
Day 4 NIAID-OS 5
|
41.0 percentage of participants
Interval 37.5 to 44.5
|
39.0 percentage of participants
Interval 35.5 to 42.5
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
Day 4 NIAID-OS 6
|
22.4 percentage of participants
Interval 19.5 to 25.4
|
21.8 percentage of participants
Interval 18.9 to 24.8
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
Day 4 NIAID-OS 8
|
1.4 percentage of participants
Interval 0.5 to 2.2
|
0.4 percentage of participants
Interval 0.0 to 0.9
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
Day 4 NIAID-OS 2
|
1.5 percentage of participants
Interval 0.6 to 2.4
|
1.5 percentage of participants
Interval 0.6 to 2.4
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
Day 4 NIAID-OS 3
|
0.8 percentage of participants
Interval 0.2 to 1.4
|
0.3 percentage of participants
Interval 0.0 to 0.7
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 4
Day 4 NIAID-OS 7
|
8.9 percentage of participants
Interval 6.8 to 10.9
|
8.1 percentage of participants
Interval 6.2 to 10.1
|
SECONDARY outcome
Timeframe: Day 7Population: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.
Overall improvement on the National Institute of Allergy and Infectious Diseases 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 - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
Outcome measures
| Measure |
Placebo + SOC
n=756 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=762 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
Day 7 NIAID-OS 1
|
20.2 percentage of participants
Interval 17.3 to 23.1
|
25.2 percentage of participants
Interval 22.1 to 28.4
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
Day 7 NIAID-OS 2
|
6.6 percentage of participants
Interval 4.8 to 8.4
|
5.8 percentage of participants
Interval 4.1 to 7.5
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
Day 7 NIAID-OS 4
|
21.2 percentage of participants
Interval 18.2 to 24.1
|
20.6 percentage of participants
Interval 17.6 to 23.5
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
Day 7 NIAID-OS 5
|
22.5 percentage of participants
Interval 19.5 to 25.5
|
22.5 percentage of participants
Interval 19.4 to 25.5
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
Day 7 NIAID-OS 3
|
0.5 percentage of participants
Interval 0.0 to 1.1
|
0.2 percentage of participants
Interval 0.0 to 0.5
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
Day 7 NIAID-OS 6
|
14.5 percentage of participants
Interval 12.0 to 17.0
|
13.8 percentage of participants
Interval 11.3 to 16.2
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
Day 7 NIAID-OS 7
|
11.2 percentage of participants
Interval 9.0 to 13.5
|
10.8 percentage of participants
Interval 8.6 to 13.0
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 7
Day 7 NIAID-OS 8
|
3.3 percentage of participants
Interval 2.0 to 4.5
|
1.2 percentage of participants
Interval 0.4 to 2.0
|
SECONDARY outcome
Timeframe: Day 10Population: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.
Overall improvement on the National Institute of Allergy and Infectious Diseases 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 - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
Outcome measures
| Measure |
Placebo + SOC
n=756 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=762 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
Day 10 NIAID-OS 2
|
9.4 percentage of participants
Interval 7.3 to 11.5
|
10.9 percentage of participants
Interval 8.7 to 13.2
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
Day 10 NIAID-OS 3
|
0.1 percentage of participants
Interval 0.0 to 0.4
|
0.1 percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
Day 10 NIAID-OS 4
|
16.2 percentage of participants
Interval 13.6 to 18.9
|
14.1 percentage of participants
Interval 11.6 to 16.6
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
Day 10 NIAID-OS 5
|
12.8 percentage of participants
Interval 10.3 to 15.2
|
12.4 percentage of participants
Interval 10.0 to 14.8
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
Day 10 NIAID-OS 6
|
8.1 percentage of participants
Interval 6.1 to 10.0
|
8.9 percentage of participants
Interval 6.8 to 11.0
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
Day 10 NIAID-OS 1
|
37.7 percentage of participants
Interval 34.2 to 41.2
|
40.4 percentage of participants
Interval 36.9 to 44.0
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
Day 10 NIAID-OS 7
|
10.6 percentage of participants
Interval 8.4 to 12.9
|
10.4 percentage of participants
Interval 8.2 to 12.6
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 10
Day 10 NIAID-OS 8
|
5.1 percentage of participants
Interval 3.5 to 6.7
|
2.6 percentage of participants
Interval 1.5 to 3.8
|
SECONDARY outcome
Timeframe: Day 14Population: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.
Overall improvement on the National Institute of Allergy and Infectious Diseases 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 - no longer requires ongoing medical care: (This would include those kept in hospital for quarantine/infection control, awaiting bed in rehabilitation facility or homecare, etc.); 4. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5. Hospitalized, requiring supplemental oxygen; 6.Hospitalized, on noninvasive ventilation or high-flow oxygen devices; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 8. Death.
Outcome measures
| Measure |
Placebo + SOC
n=756 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=762 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
Day 14 NIAID-OS 3
|
0.3 percentage of participants
Interval 0.0 to 0.6
|
0.1 percentage of participants
Interval 0.0 to 0.4
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
Day 14 NIAID-OS 4
|
8.0 percentage of participants
Interval 6.0 to 10.0
|
7.6 percentage of participants
Interval 5.7 to 9.6
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
Day 14 NIAID-OS 7
|
9.4 percentage of participants
Interval 7.3 to 11.6
|
8.9 percentage of participants
Interval 6.9 to 11.0
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
Day 14 NIAID-OS 1
|
51.6 percentage of participants
Interval 48.0 to 55.2
|
56.3 percentage of participants
Interval 52.7 to 59.9
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
Day 14 NIAID-OS 2
|
11.2 percentage of participants
Interval 8.9 to 13.5
|
11.1 percentage of participants
Interval 8.8 to 13.4
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
Day 14 NIAID-OS 5
|
8.4 percentage of participants
Interval 6.4 to 10.5
|
7.3 percentage of participants
Interval 5.4 to 9.2
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
Day 14 NIAID-OS 6
|
3.6 percentage of participants
Interval 2.2 to 4.9
|
3.7 percentage of participants
Interval 2.3 to 5.1
|
|
Percentage of Participants at Each Clinical Status Using the National Institute of Allergy and Infectious Diseases Ordinal Scale (NIAID-OS) at Day 14
Day 14 NIAID-OS 8
|
7.5 percentage of participants
Interval 5.6 to 9.4
|
4.9 percentage of participants
Interval 3.4 to 6.5
|
SECONDARY outcome
Timeframe: Days 1 to Day 28Population: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale were excluded.
Duration of hospitalization.
Outcome measures
| Measure |
Placebo + SOC
n=756 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=762 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Duration of Hospitalization
|
13.7 days
Standard Error 0.40
|
12.9 days
Standard Error 0.40
|
SECONDARY outcome
Timeframe: Day 10Population: All participants randomly assigned to study intervention whose oxygen saturation (based on National Early Warning Score) is \< 94% at baseline and have non-missing baseline and at least 1 postbaseline observation are in this population.
Percentage of participants with a change in oxygen saturation from \< 94% to ≥ 94% from baseline based on National Early Warning Score (NEWS). Measure of the oxygen level of the blood is measure by pulse oximetry. The score is determined from six physiological parameters readily measured over time in hospitalized participants: Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness, as measured by Alert Voice Pain Unresponsive (AVPU). A score is assigned to each parameter, the magnitude of the score representing the extremity of variation from the norm. A weighting score is added for participants needing supplemental oxygen (oxygen delivery by mask or by cannula) The aggregate score is reflective of the participants status.
Outcome measures
| Measure |
Placebo + SOC
n=282 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=282 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Percentage of Participants With a Change in Oxygen Saturation From < 94% to ≥ 94% From Baseline
|
52.5 percentage of participants
Interval 46.7 to 58.2
|
56.7 percentage of participants
Interval 50.9 to 62.4
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention.
Number of deaths by Day 28.
Outcome measures
| Measure |
Placebo + SOC
n=761 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=764 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Overall Mortality
|
104 event of death
|
65 event of death
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention with non-missing baseline NIAID OS and at least 1 postbaseline NIAID OS observation.
Duration of stay in the ICU in days.
Outcome measures
| Measure |
Placebo + SOC
n=754 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=758 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Duration of Stay in the Intensive Care Unit (ICU) in Days
|
3.17 days
Standard Error 0.313
|
3.19 days
Standard Error 0.315
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention. Participants with missing baseline ordinal scale values were excluded from analysis.
The National Institute of Allergy and Infectious Diseases ordinal scale (NIAID-OS) is an assessment of clinical status. The scale is as follows: 1) Not hospitalized, no limitations on activities; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 5) Hospitalized, requiring supplemental oxygen; 6) Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 7) Hospitalized, on invasive mechanical ventilation or ECMO; 8) Death. A higher score is representative of worse clinical outcome with a score of 8 being the highest and representing death.
Outcome measures
| Measure |
Placebo + SOC
n=761 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=764 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Time to Clinical Deterioration (One-category Increase on the NIAID-OS)
|
NA days
Median not evaluable due to less than half the participants meeting criteria.
|
NA days
Median not evaluable due to less than half the participants meeting criteria.
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention who had a fever at baseline.
Time to resolution of fever in participants with fever at baseline was calculated using cox proportional hazard regression model adjusted for baseline disease severity (OS 4, OS 5, OS 6), age (\<65 years, \>=65 years), region (United States, Europe, rest of world), and systemic corticosteroids used at baseline for primary study condition (Yes/No).
Outcome measures
| Measure |
Placebo + SOC
n=354 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=357 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Time to Resolution of Fever in Participants With Fever at Baseline
|
4.00 days
Interval 3.0 to 4.0
|
3.00 days
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, Day 4; Baseline, Day 7; Baseline, Day 10; Baseline, Day 14Population: All participants randomly assigned to study intervention with baseline and 1 postbaseline observation.
The NEWS score is used to detect and report changes in illness severity in participants with acute illness to identify participants at risk for poor outcomes. The score is based on six physiological parameters (Respiration rate; oxygen saturation; temperature; systolic blood pressure; heart (pulse) rate, and level of consciousness). A score is assigned to each parameter, and the sum of the score represents the participant's risk of poor outcomes with a minimum score of 0 representing the better outcome, a score of 7 or greater reflects high clinical risk for worsening and maximum score of 19 representing the worse outcome.
Outcome measures
| Measure |
Placebo + SOC
n=636 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=647 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Mean Change From Baseline on the National Early Warning Score (NEWS)
Day 4
|
-0.59 score on a scale
Standard Error 0.127
|
-0.76 score on a scale
Standard Error 0.125
|
|
Mean Change From Baseline on the National Early Warning Score (NEWS)
Day 14
|
-1.41 score on a scale
Standard Error 0.183
|
-1.66 score on a scale
Standard Error 0.182
|
|
Mean Change From Baseline on the National Early Warning Score (NEWS)
Day 7
|
-0.86 score on a scale
Standard Error 0.145
|
-1.04 score on a scale
Standard Error 0.143
|
|
Mean Change From Baseline on the National Early Warning Score (NEWS)
Day 10
|
-1.33 score on a scale
Standard Error 0.160
|
-1.45 score on a scale
Standard Error 0.158
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention who were intubated at some point during the study.
Time to definitive extubation included participants who progressed to OS 7 at any time prior to Day 28.
Outcome measures
| Measure |
Placebo + SOC
n=136 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=125 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Time to Definitive Extubation
|
NA days
Median not evaluable due to less than half the participants meeting criteria.
|
NA days
Median not evaluable due to less than half the participants meeting criteria.
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention whose baseline OS was 6 and were on non-invasive mechanical ventilation.
Time to independence from non-invasive mechanical ventilation was measured in days among participants who required non-invasive ventilation.
Outcome measures
| Measure |
Placebo + SOC
n=187 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=183 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Time to Independence From Non-Invasive Mechanical Ventilation
|
11.00 days
Interval 9.0 to 13.0
|
12.00 days
Interval 9.0 to 14.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: All randomized participants who had an ordinal scale score of 5 or 6 at baseline.
Time to independence from oxygen therapy in days.
Outcome measures
| Measure |
Placebo + SOC
n=659 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=673 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Time to Independence From Oxygen Therapy in Days
|
8.00 days
Interval 8.0 to 9.0
|
8.00 days
Interval 7.0 to 8.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention who have non-missing baseline and at least 1 postbaseline observation.
Number of days with supplemental oxygen use.
Outcome measures
| Measure |
Placebo + SOC
n=754 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=758 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Number of Days With Supplemental Oxygen Use
|
4.60 days
Standard Error 0.221
|
4.37 days
Standard Error 0.222
|
SECONDARY outcome
Timeframe: Day 1 to Day 28Population: All participants randomly assigned to study intervention who had non-missing baseline and at least 1 postbaseline respiratory rate.
Number of days of resting respiratory rate \<24 breaths per minute.
Outcome measures
| Measure |
Placebo + SOC
n=743 Participants
Placebo administered orally QD with standard of care.
|
Baricitinib + SOC
n=745 Participants
4 mg baricitinib administered orally QD with standard of care.
|
|---|---|---|
|
Number of Days of Resting Respiratory Rate <24 Breaths Per Minute
|
9.62 days
Standard Error 0.300
|
9.73 days
Standard Error 0.304
|
Adverse Events
Placebo
Serious events: 135 serious events
Other events: 0 other events
Deaths: 104 deaths
4 Milligrams (mg) Baricitinib
Serious events: 110 serious events
Other events: 0 other events
Deaths: 65 deaths
Placebo Follow-up
Serious events: 12 serious events
Other events: 0 other events
Deaths: 16 deaths
4mg Baricitinib Follow-up
Serious events: 18 serious events
Other events: 0 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Placebo
n=752 participants at risk
Placebo tablets administered orally every day (QD) with standard of care.
|
4 Milligrams (mg) Baricitinib
n=750 participants at risk
4 milligrams (mg) baricitinib administered orally QD with standard of care.
|
Placebo Follow-up
n=613 participants at risk
Participants did not receive drug during the Follow-Up Period.
|
4mg Baricitinib Follow-up
n=645 participants at risk
Participants did not receive drug during the Follow-Up Period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.27%
2/752 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Cardiac disorders
Atrial fibrillation
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Cardiac disorders
Bradycardia
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Cardiac disorders
Cardiac arrest
|
0.40%
3/752 • Number of events 3 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/613 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.80%
6/752 • Number of events 6 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.40%
3/750 • Number of events 3 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/613 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Cardiac disorders
Cardiogenic shock
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.27%
2/750 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/613 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Eye disorders
Diplopia
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
General disorders
Hypothermia
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.66%
5/752 • Number of events 5 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.53%
4/750 • Number of events 4 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/613 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Bacteraemia
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Bacterial infection
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Covid-19
|
1.3%
10/752 • Number of events 10 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
1.1%
8/750 • Number of events 8 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/613 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Covid-19 pneumonia
|
2.8%
21/752 • Number of events 21 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
2.8%
21/750 • Number of events 21 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Device related bacteraemia
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Empyema
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Pneumonia
|
1.3%
10/752 • Number of events 10 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
1.1%
8/750 • Number of events 8 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Pneumonia bacterial
|
0.40%
3/752 • Number of events 3 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.53%
4/750 • Number of events 5 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Pneumonia viral
|
0.27%
2/752 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.27%
2/750 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Sepsis
|
0.53%
4/752 • Number of events 4 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.40%
3/750 • Number of events 3 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Septic shock
|
3.2%
24/752 • Number of events 24 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
1.7%
13/750 • Number of events 13 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.65%
4/613 • Number of events 4 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.78%
5/645 • Number of events 5 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Severe acute respiratory syndrome
|
0.40%
3/752 • Number of events 3 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.27%
2/750 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.27%
2/750 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Infections and infestations
Urinary tract infection
|
0.27%
2/752 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Investigations
Fibrin d dimer increased
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Investigations
Hepatic enzyme increased
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Investigations
Transaminases increased
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Nervous system disorders
Cerebral infarction
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Nervous system disorders
Guillain-barre syndrome
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.27%
2/750 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Nervous system disorders
Neuralgia
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Nervous system disorders
Paresis
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
10/752 • Number of events 10 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.93%
7/750 • Number of events 7 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/613 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Renal and urinary disorders
Renal failure
|
0.40%
3/752 • Number of events 3 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Renal and urinary disorders
Renal impairment
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/473 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/490 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.27%
1/377 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/415 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.40%
3/752 • Number of events 3 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.27%
2/750 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/613 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.9%
29/752 • Number of events 29 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
2.3%
17/750 • Number of events 17 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/613 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.31%
2/645 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.27%
2/752 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.80%
6/750 • Number of events 6 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.93%
7/752 • Number of events 7 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
1.6%
12/750 • Number of events 12 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.53%
4/752 • Number of events 4 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.40%
3/750 • Number of events 3 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.3%
17/752 • Number of events 17 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
1.3%
10/750 • Number of events 10 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Surgical and medical procedures
Palliative care
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Vascular disorders
Deep vein thrombosis
|
0.66%
5/752 • Number of events 5 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.53%
4/750 • Number of events 4 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Vascular disorders
Dry gangrene
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.16%
1/645 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Vascular disorders
Hypotension
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.27%
2/750 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.13%
1/750 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Vascular disorders
Shock
|
0.00%
0/752 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.27%
2/750 • Number of events 2 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
|
Vascular disorders
Shock haemorrhagic
|
0.13%
1/752 • Number of events 1 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/750 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/613 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
0.00%
0/645 • Baseline up to 119 days Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
All randomized participants who received at least 1 dose of study drug including participants who entered the post-treatment follow-up (f/u) period. The main study period included all events from the start of first dose to 28 days post dose. One participant receiving baricitinib had 2 events with fatal outcomes. One event occurred in the main study period and the second event occurred in the f/u period which resulted in the participant death being counted in both the main study and f/u periods.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60