Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (NCT NCT04362137)
NCT ID: NCT04362137
Last Updated: 2021-10-11
Results Overview
Efficacy is measured by a composite endpoint of proportion of patients who die, develop respiratory failure \[require mechanical ventilation\], or require intensive care unit \[ICU\] care for the treatment of COVID-19. Analyses are cumulative, thus analysis on Day 29 includes all events till that day. Patients who developed respiratory failure and/or required ICU at randomization are excluded from the analysis.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
432 participants
Primary outcome timeframe
Day 1 - Day 29
Results posted on
2021-10-11
Participant Flow
Participants took part in 61 investigative sites in 12 countries.
Patients were to be randomized on the same day as screening or up to 2 days after completing the screening procedures.
Participant milestones
| Measure |
Ruxolitinib 5 mg
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
287
|
145
|
|
Overall Study
Safety Set
|
281
|
143
|
|
Overall Study
COMPLETED
|
269
|
139
|
|
Overall Study
NOT COMPLETED
|
18
|
6
|
Reasons for withdrawal
| Measure |
Ruxolitinib 5 mg
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Overall Study
Death
|
9
|
3
|
|
Overall Study
Patient decision
|
6
|
3
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol deviation
|
1
|
0
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm
Baseline characteristics by cohort
| Measure |
Ruxolitinib 5 mg
n=287 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
Total
n=432 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
162 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
235 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
242 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
351 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian Or Alaska Native
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black Or African American
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 - Day 29Population: Randomized participants excluding those who developed respiratory failure and/or required ICU at randomization.
Efficacy is measured by a composite endpoint of proportion of patients who die, develop respiratory failure \[require mechanical ventilation\], or require intensive care unit \[ICU\] care for the treatment of COVID-19. Analyses are cumulative, thus analysis on Day 29 includes all events till that day. Patients who developed respiratory failure and/or required ICU at randomization are excluded from the analysis.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=284 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=144 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care
|
34 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Randomized participants with a valid assessment for the outcome measure.
Clinical status is measured with the 9-point ordinal scale. The scoring is: * Uninfected patients have a score 0 (no clinical or virological evidence of infection). * Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities). * Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as peripheral oxygen saturation (SpO2) ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs). * Hospitalized patients with severe disease can have score 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)). * Patients who die have a score 8.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=287 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Clinical Status
Baseline
|
3.7 score on scale
Standard Deviation 0.56
|
3.7 score on scale
Standard Deviation 0.53
|
|
Clinical Status
Day 15
|
1.8 score on scale
Standard Deviation 1.54
|
1.8 score on scale
Standard Deviation 1.41
|
|
Clinical Status
Day 29
|
1.1 score on scale
Standard Deviation 1.61
|
1.0 score on scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Randomized participants with a valid assessment of clinical status at baseline.
Percentage of patients with at least two points improvement in clinical status on the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are treated as non-responders.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=286 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Percentage of Patients With at Least Two-point Improvement From Baseline in Clinical Status
Day 15
|
206 Participants
|
108 Participants
|
|
Percentage of Patients With at Least Two-point Improvement From Baseline in Clinical Status
Day 29
|
252 Participants
|
129 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Randomized participants with a valid assessment of clinical status at baseline.
Percentage of patients with at least one point improvement in clinical status on the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are treated as non-responders.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=286 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Percentage of Patients With at Least One-point Improvement From Baseline in Clinical Status
Day 15
|
250 Participants
|
128 Participants
|
|
Percentage of Patients With at Least One-point Improvement From Baseline in Clinical Status
Day 29
|
261 Participants
|
136 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Randomized participants with a valid assessment of clinical status at baseline.
Percentage of patients with at least one point deterioration in clinical status on the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are treated as non-responders.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=286 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Percentage of Patients With at Least One-point Deterioration From Baseline in Clinical Status
Day 15
|
16 Participants
|
9 Participants
|
|
Percentage of Patients With at Least One-point Deterioration From Baseline in Clinical Status
Day 29
|
14 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 29 daysPopulation: Randomized participants with a valid assessment of clinical status at baseline.
Time to improvement in clinical status from baseline category to one less severe category of the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Median time to improvement is estimated by Kaplan-Meier method, with dead patients being censored at the maximum follow-up time in the study. Patients who did not achieve improvement and did not die are censored at their last clinical status assessment date.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=286 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Time to Improvement in Clinical Status
|
9.0 days
Interval 8.0 to 10.0
|
9.0 days
Interval 8.0 to 12.0
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Randomized participants with a valid assessment for the outcome measure.
Mean change from baseline in the 9-point ordinal scale. The baseline value of clinical status is defined as the last assessment prior to first dose of double-blind treatment. Patients with missing data at Day 15 and/or Day 29 are excluded from the analysis. A negative change from baseline in the clinical status is a favorable outcome.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=287 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Mean Change From Baseline in the Clinical Status
Day 15
|
-1.96 score on scale
Standard Error 0.084
|
-1.93 score on scale
Standard Error 0.118
|
|
Mean Change From Baseline in the Clinical Status
Day 29
|
-2.61 score on scale
Standard Error 0.090
|
-2.69 score on scale
Standard Error 0.126
|
SECONDARY outcome
Timeframe: Day 15, Day 29Population: All randomized participants including those who did not receive any dose, as per intent-to-treat principle, and excluding patients lost to follow up.
Mortality rate is determined as the proportion of participants who died by study Day 15 and Day 29
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=287 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Mortality Rate
Day 15
|
6 Participants
|
2 Participants
|
|
Mortality Rate
Day 29
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 - Day 29Population: Randomized participants with a valid assessment for the outcome measure.
Proportion of patients requiring mechanical ventilation. Analyses are cumulative, thus analysis on Day 29 includes all events till that day. Patients who required mechanical ventilation at randomization are excluded from the analysis.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=286 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Proportion of Patients Requiring Mechanical Ventilation
|
22 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 29 daysPopulation: Randomized participants with a valid assessment for the outcome measure.
Duration of hospitalization is defined as time to hospital discharge. Median time to hospital discharge is estimated by Kaplan-Meier method, with dead patients being censored at the maximum follow-up time in the study. Patients who were not discharged and did not die are censored at their last assessment date.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=286 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Duration of Hospitalization
|
9.0 days
Interval 8.0 to 10.0
|
9.0 days
Interval 8.0 to 12.0
|
SECONDARY outcome
Timeframe: 29 daysPopulation: Randomized participants with a valid assessment for the outcome measure.
The time to hospital discharge or to a National Early Warning Score 2 (NEWS2) of ≤2 and maintained for 24 hours whichever comes first. The NEWS2 is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice presentation or when a patient is being monitored in hospital. The score ranges from 0 (best) to 23 (worst). Median time is estimated by Kaplan-Meier method, with dead patients being censored at the maximum follow-up time in the study.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=286 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Time to Hospital Discharge or to a NEWS2 Score of ≤2
|
4.0 days
Interval 3.0 to 4.0
|
4.0 days
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline, Days 3, 5, 8, 11, 15, and 29Population: Randomized participants with a valid assessment for the outcome measure.
The National Early Warning Score 2 (NEWS2) is based on a simple aggregate scoring system in which a score is allocated to physiological measurements, already recorded in routine practice presentation or when a patient is being monitored in hospital. The score ranges from 0 (best) to 23 (worst). At each visit, only patients with a value at both baseline and the respective visit are included. A negative change from baseline in NEWS2 score is a favorable outcome.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=287 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Change From Baseline in NEWS2 Score
Day 3
|
-0.7 score on scale
Standard Deviation 1.91
|
-0.6 score on scale
Standard Deviation 2.13
|
|
Change From Baseline in NEWS2 Score
Day 5
|
-1.0 score on scale
Standard Deviation 2.02
|
-0.8 score on scale
Standard Deviation 2.19
|
|
Change From Baseline in NEWS2 Score
Day 8
|
-1.3 score on scale
Standard Deviation 2.25
|
-1.3 score on scale
Standard Deviation 2.60
|
|
Change From Baseline in NEWS2 Score
Day 11
|
-1.1 score on scale
Standard Deviation 2.70
|
-1.3 score on scale
Standard Deviation 2.74
|
|
Change From Baseline in NEWS2 Score
Day 15
|
-1.9 score on scale
Standard Deviation 2.34
|
-2.2 score on scale
Standard Deviation 2.35
|
|
Change From Baseline in NEWS2 Score
Day 29
|
-2.3 score on scale
Standard Deviation 2.37
|
-2.5 score on scale
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 29Population: Randomized participants with a valid assessment of the outcome measure.
Change from baseline in peripheral oxygen saturation / fraction of inspired oxygen ratio (SpO2/FiO2 ratio). At each visit, only patients with a value at both baseline and the respective visit are included. A positive change from baseline in SpO2/FiO2 ratio is a favorable outcome.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=287 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Change From Baseline in SpO2/FiO2 Ratio
Day 15
|
90.110 no units
Standard Deviation 104.4783
|
106.766 no units
Standard Deviation 100.9778
|
|
Change From Baseline in SpO2/FiO2 Ratio
Day 29
|
105.553 no units
Standard Deviation 98.2452
|
109.710 no units
Standard Deviation 95.4279
|
SECONDARY outcome
Timeframe: Day 15, Day 29Population: Randomized participants with a valid assessment of the outcome measure.
Proportion of patients with no oxygen therapy (defined as oxygen saturation ≥ 94% on room air) at Days 15 and 29. Analyses are cumulative, thus analysis on each day includes all events till that day. Patients with missing data at Day 15 and/or Day 29 are excluded from the analysis.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=287 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Proportion of Patients With no Oxygen Therapy
Day 29
|
262 Participants
|
136 Participants
|
|
Proportion of Patients With no Oxygen Therapy
Day 15
|
255 Participants
|
133 Participants
|
POST_HOC outcome
Timeframe: 29 daysPopulation: Clinical database population - all randomized participants
Deaths in the safety population were evaluated in all participants who received at least one dose of double-blind treatment. Total deaths were evaluated in all participants randomized.
Outcome measures
| Measure |
Ruxolitinib 5 mg
n=287 Participants
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=145 Participants
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
All Collected Deaths
Deaths in the safety population
|
9 participants
|
3 participants
|
|
All Collected Deaths
Total deaths
|
9 participants
|
3 participants
|
Adverse Events
Ruxolitinib 5 mg
Serious events: 31 serious events
Other events: 113 other events
Deaths: 9 deaths
Placebo
Serious events: 15 serious events
Other events: 62 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Ruxolitinib 5 mg
n=281 participants at risk
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=143 participants at risk
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.70%
1/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.70%
1/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
General disorders
Adverse event
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
General disorders
General physical health deterioration
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.70%
1/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
General disorders
Performance status decreased
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Antibiotic associated colitis
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Bacteraemia
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
COVID-19
|
2.8%
8/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.1%
3/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.70%
1/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Pneumonia
|
1.1%
3/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Pneumonia fungal
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.70%
1/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.70%
1/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.70%
1/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Investigations
Transaminases increased
|
0.00%
0/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.70%
1/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.70%
1/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
4/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.70%
1/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.4%
4/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.8%
4/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.71%
2/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.4%
2/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Vascular disorders
Shock
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
Other adverse events
| Measure |
Ruxolitinib 5 mg
n=281 participants at risk
Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days
|
Placebo
n=143 participants at risk
Matching-image placebo for 14 days with possible extension of treatment to 28 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.4%
4/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.8%
4/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.1%
6/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.8%
4/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.1%
6/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
4.2%
6/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.1%
6/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.1%
3/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
4/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.8%
4/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.2%
9/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
4.9%
7/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.5%
21/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
8.4%
12/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
6/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
7.7%
11/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
General disorders
Asthenia
|
2.1%
6/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.00%
0/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
General disorders
Fatigue
|
3.6%
10/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.4%
2/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
General disorders
Pyrexia
|
2.1%
6/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.4%
2/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
3/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.8%
4/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
17/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
4.2%
6/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
5/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.1%
3/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Investigations
Transaminases increased
|
2.5%
7/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
1.4%
2/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
4/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
3.5%
5/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.8%
8/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
4.9%
7/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.36%
1/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.1%
3/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
1.4%
4/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.1%
3/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Nervous system disorders
Dizziness
|
0.71%
2/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.8%
4/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Nervous system disorders
Headache
|
8.2%
23/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
7.7%
11/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Psychiatric disorders
Anxiety
|
2.1%
6/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
0.70%
1/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Psychiatric disorders
Insomnia
|
1.1%
3/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.8%
4/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
12/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.1%
3/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
3/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.1%
3/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
|
Vascular disorders
Hypertension
|
1.4%
4/281 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
2.1%
3/143 • From first dose of double-blind treatment and up to the last study visit (Day 29).
Adverse events are considered as treatment-emergent if the event started after the first dose of double-blind treatment or the event was present prior to start of double-blind treatment but increased in severity based on preferred term and up to the last study visit (Day 29). Adverse events and all-cause mortality are evaluated in the Safety Set that includes all participants who received at least one dose of double-blind treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. Novartis does not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER