Trial Outcomes & Findings for Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT) (NCT NCT04377620)
NCT ID: NCT04377620
Last Updated: 2022-01-19
Results Overview
To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
211 participants
Primary outcome timeframe
Study start to Day 29
Results posted on
2022-01-19
Participant Flow
This study was conducted at 33 study centers in the United States (29) and Russia (4), and 211 participants were enrolled and analyzed for efficacy.; 209 participants were analyzed for safety. Enrollment in this study was stopped early and was not due to safety reasons.
Participants were randomly assigned in a 2:2:1 ratio to receive ruxolitinib 5 mg BID, ruxolitinib 15 mg BID, or placebo for an initial treatment period of 14 days; participants randomly assigned to receive placebo were randomly assigned in a 1:1 ratio to receive placebo matching ruxolitinib 5 mg BID or placebo matching ruxolitinib 15 mg BID. Randomization was stratified by ARDS severity (severe vs mild/moderate at the time of randomization) and investigative site.
Participant milestones
| Measure |
Ruxolitininb 15mg + Standard of Care
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Overall Study
STARTED
|
77
|
87
|
47
|
|
Overall Study
COMPLETED
|
35
|
37
|
11
|
|
Overall Study
NOT COMPLETED
|
42
|
50
|
36
|
Reasons for withdrawal
| Measure |
Ruxolitininb 15mg + Standard of Care
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Overall Study
Death
|
42
|
48
|
36
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Baseline characteristics by cohort
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=87 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
149 Participants
n=7 Participants
|
|
Age, Continuous
|
63.6 Years
STANDARD_DEVIATION 12.92 • n=99 Participants
|
63.6 Years
STANDARD_DEVIATION 12.25 • n=107 Participants
|
62.5 Years
STANDARD_DEVIATION 13.34 • n=206 Participants
|
63.4 Years
STANDARD_DEVIATION 12.69 • n=7 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
74 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
137 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
151 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Study start to Day 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
To evaluate the 28-day mortality rate of ruxolitinib 5 mg BID + SoC therapy and ruxolitinib 15 mg BID + SoC compared with placebo + SoC therapy, in participants with COVID-19-associated ARDS who require mechanical ventilation.
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=85 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Percentage of Participants Who Have Died Due to Any Cause
|
50.6 Percentage
|
52.9 Percentage
|
70.2 Percentage
|
SECONDARY outcome
Timeframe: Study start to Day 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Number of days participant did not require mechanical ventilation
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=85 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Number of Ventilator Free Days
|
6.31 Days
Standard Deviation 9.047
|
4.92 Days
Standard Deviation 8.398
|
2.98 Days
Standard Deviation 7.228
|
SECONDARY outcome
Timeframe: Study start to Day 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Number of days participant is out of the ICU
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=85 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Number of ICU Free Days
|
4.75 Days
Standard Deviation 7.716
|
4.00 Days
Standard Deviation 7.517
|
2.45 Days
Standard Deviation 6.362
|
SECONDARY outcome
Timeframe: Study start to Day 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Number of days participant did not receive supplemental oxygen
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=85 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Oxygen Free Days
|
2.66 Days
Standard Deviation 6.073
|
2.98 Days
Standard Deviation 6.745
|
1.53 Days
Standard Deviation 4.690
|
SECONDARY outcome
Timeframe: Study start to Day 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Number of days without use of vasopressor therapy
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=85 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Vasopressor Free Days
|
8.95 Days
Standard Deviation 11.738
|
7.53 Days
Standard Deviation 10.861
|
4.47 Days
Standard Deviation 9.322
|
SECONDARY outcome
Timeframe: Study start to Day 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Number of days Partcipant is out of the hospital
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=85 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Hospital Free Days
|
2.09 Days
Standard Deviation 4.889
|
2.35 Days
Standard Deviation 5.259
|
1.38 Days
Standard Deviation 3.976
|
SECONDARY outcome
Timeframe: Study start to Days 15 and 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Participants with at least 2-point improvement at Day 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=87 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale
Day 15
|
22.1 Percentage of Participants
Interval 13.4 to
|
15.3 Percentage of Participants
Interval 8.4 to 24.7
|
10.6 Percentage of Participants
Interval 3.5 to 23.1
|
|
Percentage of Participants With at Least 2-point Improvement in the COVID-19 Ordinal Scale
Day 29
|
29.7 Percentage of Participants
Interval 19.7 to 41.5
|
25.3 Percentage of Participants
Interval 16.4 to 36.0
|
17.0 Percentage of Participants
Interval 7.6 to 30.8
|
SECONDARY outcome
Timeframe: Study start to Days 15 and 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
Participants with at lest 1-point improvement in clinical status at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=87 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale
Day 29
|
43.2 Percentage of Participants
Interval 31.8 to 55.3
|
32.5 Percentage of Participants
Interval 22.6 to 43.7
|
17.0 Percentage of Participants
Interval 7.6 to 30.8
|
|
Percentage of Participants With at Least 1-point Improvement in the COVID-19 Ordinal Scale
Day 15
|
41.6 Percentage of Participants
Interval 30.4 to 53.4
|
32.9 Percentage of Participants
Interval 23.1 to 44.0
|
21.3 Percentage of Participants
Interval 10.7 to 35.7
|
SECONDARY outcome
Timeframe: Study Start to Day 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study.
TIme to improvement compared to baseline. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=50 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=49 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=20 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Time to Improvement From Baseline Category to Earliest 1-point Improvement in the COVID-19 Ordinal Scale
|
0.91 Days
Interval 0.711 to 0.992
|
0.75 Days
Interval 0.614 to 0.867
|
0.61 Days
Interval 0.408 to 0.818
|
SECONDARY outcome
Timeframe: Study start to Day 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. Please note that in the 15mg BID arm, 3 participants were missing scale reporting on Day 29. In the 5mg BID, 2 participants were lost to follow-up, and 2 were missing scale reporting.
Clinical status of participant at Day 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=74 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=83 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Percentage of Participants With the COVID-19 Ordinal Scale Reported
Score 0 = Uninfected
|
0 Percentage
|
4.6 Percentage
|
0 Percentage
|
|
Percentage of Participants With the COVID-19 Ordinal Scale Reported
Score 1 = Ambulatory (no limitation of activities)
|
2.6 Percentage
|
0 Percentage
|
2.1 Percentage
|
|
Percentage of Participants With the COVID-19 Ordinal Scale Reported
Score 2 = Ambulatory (limitation of activities)
|
16.9 Percentage
|
16.1 Percentage
|
10.6 Percentage
|
|
Percentage of Participants With the COVID-19 Ordinal Scale Reported
Score 3 = Hospitalized/Mild Disease (no oxygen therapy)
|
0 Percentage
|
1.1 Percentage
|
0 Percentage
|
|
Percentage of Participants With the COVID-19 Ordinal Scale Reported
Score 4 = Hospitalized/Mild Disease (oxygen therapy via mask or nasal prongs)
|
9.1 Percentage
|
1.1 Percentage
|
4.3 Percentage
|
|
Percentage of Participants With the COVID-19 Ordinal Scale Reported
Score 5 = Hospitalized/Severe Disease (non-invasive ventilation or high-flow oxygen)
|
3.9 Percentage
|
4.6 Percentage
|
0.0 Percentage
|
|
Percentage of Participants With the COVID-19 Ordinal Scale Reported
Score 6 = Hospitalized/Severe Disease (intubationand mechanical ventilization)
|
10.4 Percentage
|
8.0 Percentage
|
2.1 Percentage
|
|
Percentage of Participants With the COVID-19 Ordinal Scale Reported
Score 7 = Hospitalized/Severe Disease (ventilation + additional organ support)
|
2.6 Percentage
|
8.0 Percentage
|
10.6 Percentage
|
|
Percentage of Participants With the COVID-19 Ordinal Scale Reported
Score 8 - Death
|
50.6 Percentage
|
51.7 Percentage
|
70.2 Percentage
|
SECONDARY outcome
Timeframe: Study start to Days 15 and 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. In the 15mg BID arm, 3 participants were missing scale reportingon Day 29. IN the 5mg BID, 2 participants were lost to follow-up, and 2 were missing scale reporting.
Change in the Clinical status of participant at Days 15 and 29 based on participant state. The scale ranges from 0-8 with 0 being no clinical or virological evidence of infection and 8 being dead
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=87 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Change in the COVID-19 9-point Ordinal Scale
Change from Day 1 to Day 15
|
-0.4 Score on a Scale
Standard Deviation 1.80
|
-0.2 Score on a Scale
Standard Deviation 1.73
|
0.6 Score on a Scale
Standard Deviation 1.69
|
|
Change in the COVID-19 9-point Ordinal Scale
Change from Day 1 to Day 29
|
-0.5 Score on a Scale
Standard Deviation 2.53
|
-0.4 Score on a Scale
Standard Deviation 2.57
|
0.4 Score on a Scale
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: from baseline to Days 3, 5, 8, 11, 15, and 29Population: ITT population is defined according to the treatment assignment at the time of randomization regardless of the actual study drug the participant might take during his/her participation in the study. Numbers of participants decreased after Day 1 because data was no longer collected if a patient was discharged from ICU and/or deceased.
Sequential Organ Failure Assessment (SOFA) score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on 6 different scores, 1 each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=87 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=47 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Change in SOFA Score
Baseline - Day 1
|
9.2 Scores on a Scale
Standard Deviation 2.35
|
9.6 Scores on a Scale
Standard Deviation 2.53
|
9.4 Scores on a Scale
Standard Deviation 2.69
|
|
Change in SOFA Score
Day 3
|
-0.1 Scores on a Scale
Standard Deviation 2.77
|
0.4 Scores on a Scale
Standard Deviation 3.14
|
2.6 Scores on a Scale
Standard Deviation 5.89
|
|
Change in SOFA Score
Day 5
|
0.2 Scores on a Scale
Standard Deviation 4.27
|
0.7 Scores on a Scale
Standard Deviation 4.58
|
3.3 Scores on a Scale
Standard Deviation 6.60
|
|
Change in SOFA Score
Day 8
|
1.9 Scores on a Scale
Standard Deviation 6.77
|
2.0 Scores on a Scale
Standard Deviation 6.30
|
4.5 Scores on a Scale
Standard Deviation 7.87
|
|
Change in SOFA Score
Day 11
|
2.5 Scores on a Scale
Standard Deviation 7.64
|
2.0 Scores on a Scale
Standard Deviation 7.02
|
6.5 Scores on a Scale
Standard Deviation 8.26
|
|
Change in SOFA Score
Day 15
|
4.2 Scores on a Scale
Standard Deviation 9.24
|
4.1 Scores on a Scale
Standard Deviation 7.72
|
10.3 Scores on a Scale
Standard Deviation 7.89
|
|
Change in SOFA Score
Day 29
|
10.3 Scores on a Scale
Standard Deviation 8.54
|
10.4 Scores on a Scale
Standard Deviation 7.04
|
12.8 Scores on a Scale
Standard Deviation 5.41
|
SECONDARY outcome
Timeframe: Study start to Day 29Population: The safety population includes all participants who received at least 1 dose of ruxolitinib/placebo.
Treatment-emergent AEs are judged as related by the investigator or have a missing causality.
Outcome measures
| Measure |
Ruxolitininb 15mg + Standard of Care (SoC)
n=77 Participants
Ruxolitinib 15mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Ruxolitinib 5mg + Standard of Care (SoC)
n=87 Participants
Ruxolitinib 5mg was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
Placebo + Standard of Care (SoC)
n=45 Participants
Matching Placebo was administered BID approximately 12 hours apart without regard to food/feeding via enteric feeding tube or oral.
|
|---|---|---|---|
|
Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events
Treatment-Emergent Adverse Events (TEAEs)
|
22 Participants
|
23 Participants
|
11 Participants
|
|
Number and Percentage of Participants With Treatment-related Side Effects and Serious Adverse Events
Serious TEAEs
|
23 Participants
|
21 Participants
|
11 Participants
|
Adverse Events
Ruxolitinib 15 mg BID
Serious events: 23 serious events
Other events: 35 other events
Deaths: 42 deaths
Ruxolitinib 5 mg BID
Serious events: 21 serious events
Other events: 46 other events
Deaths: 48 deaths
Placebo
Serious events: 11 serious events
Other events: 21 other events
Deaths: 36 deaths
Total
Serious events: 55 serious events
Other events: 102 other events
Deaths: 124 deaths
Serious adverse events
| Measure |
Ruxolitinib 15 mg BID
n=77 participants at risk
Ruxolitinib 15 mg BID
|
Ruxolitinib 5 mg BID
n=87 participants at risk
Ruxolitinib 5 mg BID
|
Placebo
n=45 participants at risk
Placebo
|
Total
n=209 participants at risk
Total
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.96%
2/209 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Metabolism and nutrition disorders
Acidosis
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.3%
2/87 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.4%
3/209 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Investigations
Alanine aminotransferase increased
|
3.9%
3/77 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.4%
5/209 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
2/77 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.9%
4/209 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Cardiac disorders
Atrioventricular block complete
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.3%
2/87 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.96%
2/209 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Investigations
Blood creatinine increased
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Cardiac disorders
Cardiopulmonary failure
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.4%
3/209 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.3%
2/87 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.96%
2/209 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Vascular disorders
Deep vein thrombosis
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Product Issues
Device dislocation
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Fungaemia
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Vascular disorders
Haematoma
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Renal and urinary disorders
Haematuria
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Hepatic infection
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Vascular disorders
Hypertension
|
2.6%
2/77 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.4%
3/209 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Vascular disorders
Hypotension
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
3.4%
3/87 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.4%
5/209 • Number of events 6 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
6.7%
3/45 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.4%
5/209 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.3%
2/87 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.96%
2/209 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Investigations
Oxygen saturation decreased
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.3%
2/87 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.96%
2/209 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Pneumonia
|
2.6%
2/77 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.6%
4/87 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.4%
2/45 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
3.8%
8/209 • Number of events 9 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Pneumonia staphylococcal
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.96%
2/209 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.9%
3/77 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.9%
4/209 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Cardiac disorders
Pulseless electrical activity
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.96%
2/209 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.96%
2/209 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Sepsis
|
3.9%
3/77 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.9%
4/209 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Vascular disorders
Shock
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Staphylococcal sepsis
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Strongyloidiasis
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/77 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/87 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.48%
1/209 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Vascular device infection
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
1.1%
1/87 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.96%
2/209 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
Other adverse events
| Measure |
Ruxolitinib 15 mg BID
n=77 participants at risk
Ruxolitinib 15 mg BID
|
Ruxolitinib 5 mg BID
n=87 participants at risk
Ruxolitinib 5 mg BID
|
Placebo
n=45 participants at risk
Placebo
|
Total
n=209 participants at risk
Total
|
|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
11.7%
9/77 • Number of events 9 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
13.8%
12/87 • Number of events 13 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
11.1%
5/45 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
12.4%
26/209 • Number of events 27 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Blood and lymphatic system disorders
Anaemia
|
15.6%
12/77 • Number of events 13 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
24.1%
21/87 • Number of events 23 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
20.0%
9/45 • Number of events 9 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
20.1%
42/209 • Number of events 45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Psychiatric disorders
Anxiety
|
7.8%
6/77 • Number of events 6 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.6%
4/87 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
5.3%
11/209 • Number of events 11 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Investigations
Aspartate aminotransferase increased
|
13.0%
10/77 • Number of events 10 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
12.6%
11/87 • Number of events 12 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
6.7%
3/45 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
11.5%
24/209 • Number of events 25 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Cardiac disorders
Atrial fibrillation
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
5.7%
5/87 • Number of events 6 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
6.7%
3/45 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.3%
9/209 • Number of events 10 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Bacteraemia
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
5.7%
5/87 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.9%
6/209 • Number of events 6 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Gastrointestinal disorders
Constipation
|
6.5%
5/77 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.6%
4/87 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.4%
2/45 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
5.3%
11/209 • Number of events 11 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
3.9%
3/77 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.6%
4/87 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
6.7%
3/45 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.8%
10/209 • Number of events 13 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.9%
3/77 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
9.2%
8/87 • Number of events 9 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
5.7%
12/209 • Number of events 14 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.2%
4/77 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
3.4%
3/87 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
6.7%
3/45 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.8%
10/209 • Number of events 10 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
6.5%
5/77 • Number of events 7 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.6%
4/87 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.8%
10/209 • Number of events 12 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
10.4%
8/77 • Number of events 13 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
8.0%
7/87 • Number of events 8 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
15.6%
7/45 • Number of events 7 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
10.5%
22/209 • Number of events 28 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Vascular disorders
Hypertension
|
6.5%
5/77 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
12.6%
11/87 • Number of events 12 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
11.1%
5/45 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
10.0%
21/209 • Number of events 22 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.3%
1/77 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
8.0%
7/87 • Number of events 7 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
8.9%
4/45 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
5.7%
12/209 • Number of events 12 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.7%
9/77 • Number of events 11 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
10.3%
9/87 • Number of events 11 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
8.9%
4/45 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
10.5%
22/209 • Number of events 26 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.9%
3/77 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.3%
2/87 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
6.7%
3/45 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
3.8%
8/209 • Number of events 10 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.5%
5/77 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
6.9%
6/87 • Number of events 8 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.4%
2/45 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
6.2%
13/209 • Number of events 15 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Vascular disorders
Hypotension
|
5.2%
4/77 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
3.4%
3/87 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.4%
2/45 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.3%
9/209 • Number of events 10 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Investigations
Lymphocyte count decreased
|
3.9%
3/77 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.6%
4/87 • Number of events 7 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
6.7%
3/45 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.8%
10/209 • Number of events 16 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
General disorders
Oedema peripheral
|
2.6%
2/77 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
5.7%
5/87 • Number of events 6 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
0.00%
0/45 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
3.3%
7/209 • Number of events 8 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Infections and infestations
Pneumonia staphylococcal
|
6.5%
5/77 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.3%
2/87 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
3.8%
8/209 • Number of events 8 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
General disorders
Pyrexia
|
2.6%
2/77 • Number of events 2 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
5.7%
5/87 • Number of events 7 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
8.9%
4/45 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
5.3%
11/209 • Number of events 13 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
3.9%
3/77 • Number of events 4 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
5.7%
5/87 • Number of events 6 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
6.7%
3/45 • Number of events 3 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
5.3%
11/209 • Number of events 13 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
5/77 • Number of events 10 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.6%
4/87 • Number of events 5 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
2.2%
1/45 • Number of events 1 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
4.8%
10/209 • Number of events 16 • Up to approximately 2 months.
All-Cause Mortality was monitored in all randomized participants and Serious and Other Adverse Events were assessed only in participants who received the intervention (i.e. the safety population).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER