Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19 (NCT NCT04412668)
NCT ID: NCT04412668
Last Updated: 2023-08-18
Results Overview
TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. AEs were defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Baseline up to Day 60
Results posted on
2023-08-18
Participant Flow
Participant milestones
| Measure |
Efzofitimod 1 mg/kg
Participants received single dose of efzofitimod 1 milligrams/kilograms (mg/kg) intravenous (IV) infusion on Day 1.
|
Efzofitimod 3 mg/kg
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
10
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
10
|
12
|
10
|
|
Overall Study
COMPLETED
|
7
|
12
|
10
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
0
|
Reasons for withdrawal
| Measure |
Efzofitimod 1 mg/kg
Participants received single dose of efzofitimod 1 milligrams/kilograms (mg/kg) intravenous (IV) infusion on Day 1.
|
Efzofitimod 3 mg/kg
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Overall Study
Death - multiple comorbidities
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
0
|
|
Overall Study
Other than Specified
|
2
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Safety and Efficacy of ATYR1923 (Efzofitimod) In Participants With Severe Pneumonia Related to COVID-19
Baseline characteristics by cohort
| Measure |
Efzofitimod 1 mg/kg
n=10 Participants
Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1.
|
Efzofitimod 3 mg/kg
n=12 Participants
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
n=10 Participants
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.9 years
STANDARD_DEVIATION 11.08 • n=5 Participants
|
56.5 years
STANDARD_DEVIATION 11.41 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 10.51 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 10.80 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 60Population: Safety Set was included all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
TEAEs were defined as adverse events (AEs) with an onset following administration of the first dose of study drug. AEs were defined as any untoward medical occurrence in a participant administered study drug and that does not necessarily have a causal relationship with the study drug. Worsening of a pre-existing medical condition should have been considered an AE if there was either an increase in severity, frequency, or duration of the condition or an association with significantly worse outcomes. SAEs were defined as any AE that, in the view of either the Investigator or Sponsor, resulted in any of the following outcomes as fatal, life-threatening, required in-participant hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, an important medical event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in 'Reported Adverse Events' Section.
Outcome measures
| Measure |
Efzofitimod 1 mg/kg
n=10 Participants
Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1.
|
Efzofitimod 3 mg/kg
n=12 Participants
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
n=10 Participants
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
8 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
5 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 60Population: Modified intention-to-treat set (mITT Set) included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group).
Time to hospital discharge was based on Kaplan-Meier estimate and was calculated as: discharge date - study drug administration date. Participants who died during hospitalization were censored at death date. Participants who remained hospitalized at end of study (EOS) were censored at EOS visit.
Outcome measures
| Measure |
Efzofitimod 1 mg/kg
n=10 Participants
Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1.
|
Efzofitimod 3 mg/kg
n=12 Participants
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
n=10 Participants
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Time to Hospital Discharge
|
7.0 days
Interval 3.0 to 31.0
|
5.5 days
Interval 2.0 to 6.0
|
4.5 days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline up to Day 60Population: mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group).
Time to recovery was based on Kaplan-Meier estimate and was calculated as: date of first time with a WHO scale score ≤3 - study drug administration date or date of discharge from hospital - study drug administration date, whichever occurred first. In the case that a participant did not reach WHO scale score ≤3 criteria, the participant was censored at EOS visit.
Outcome measures
| Measure |
Efzofitimod 1 mg/kg
n=10 Participants
Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1.
|
Efzofitimod 3 mg/kg
n=12 Participants
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
n=10 Participants
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Time to Recovery (World Health Organization [WHO] Ordinal Scale Score ≤3)
|
7.0 days
Interval 2.0 to 31.0
|
5.5 days
Interval 2.0 to 6.0
|
4.5 days
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline through Day 14 and Day 28Population: mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group). Here, Number of Participants Analyzed signifies those who were evaluable for this outcome measure and Number Analyzed signifies those who were evaluable at the specified timepoint.
The number of participants was the non-missing value at the visit, which was used as the denominator for percentage calculation.
Outcome measures
| Measure |
Efzofitimod 1 mg/kg
n=6 Participants
Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1.
|
Efzofitimod 3 mg/kg
n=12 Participants
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
n=10 Participants
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Number of Participants Who Achieved Recovery (WHO Ordinal Scale Score ≤3) by Day 14 and Day 28
Day 28
|
5 Participants
|
11 Participants
|
9 Participants
|
|
Number of Participants Who Achieved Recovery (WHO Ordinal Scale Score ≤3) by Day 14 and Day 28
Day 14
|
4 Participants
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 60Population: mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group).
Number of days with supplemental O2 was calculated as stop date of supplemental O2 - start date of supplemental oxygen +1, if supplemental O2 started after study drug administration; otherwise, number of days with supplemental O2 was calculated as stop date of supplemental O2 - date of study drug administration +1. If there were multiple periods of supplemental O2, total days were the sum of each period.
Outcome measures
| Measure |
Efzofitimod 1 mg/kg
n=10 Participants
Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1.
|
Efzofitimod 3 mg/kg
n=12 Participants
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
n=10 Participants
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Number of Days With Supplemental Oxygen (O2)
|
10.4 days
Standard Deviation 17.65
|
13.7 days
Standard Deviation 16.05
|
10.1 days
Standard Deviation 15.72
|
SECONDARY outcome
Timeframe: Baseline up to Day 14Population: mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group).
Number of days with fever was calculated as stop date of fever - start date of fever +1, if fever started after study drug administration; otherwise, number of days with fever was calculated as stop date of fever - date of study drug administration +1. If there were multiple periods of fever, total days was the sum of each period.
Outcome measures
| Measure |
Efzofitimod 1 mg/kg
n=10 Participants
Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1.
|
Efzofitimod 3 mg/kg
n=12 Participants
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
n=10 Participants
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Number of Days With Fever (Temperature >100.4ºF [38.0ºC])
|
0.1 days
Standard Deviation 0.32
|
0.1 days
Standard Deviation 0.29
|
0.0 days
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Baseline, Day 60Population: mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group). Here, Number of Participants analyzed signifies those who were evaluable for this outcome measure.
WHO ordinal scale rated the clinical improvement of the participants on a scale of 0-8, where 0=No clinical or virological evidence of infection, 1=No limitation of activities, 2=limitation of activities, 3=Hospitalized, no oxygen therapy, 4=Oxygen by mask or nasal prongs, 5=Non-invasive ventilation or high flow oxygen, 6=Intubation and mechanical ventilation, 7=Ventilation + additional organ support, 8=Death. Change from Baseline data were represented on a scale of -7 to 4, where -7=a better change from Baseline score and 4=a worse change from Baseline score. Change from Baseline was derived as: visit value - Baseline value.
Outcome measures
| Measure |
Efzofitimod 1 mg/kg
n=6 Participants
Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1.
|
Efzofitimod 3 mg/kg
n=12 Participants
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
n=10 Participants
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
-7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
-6
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
-5
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
-4
|
2 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
-3
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
-2
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With a Change From Baseline in World Health Organization (WHO) Ordinal Scale Score on Day 60
-1
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 60Population: mITT set included all participants randomized who had received any amount of study drug. Participants were summarized and analyzed 'as randomized' (that is, by randomized treatment group).
Time to improvement was based on Kaplan-Meier estimate and was defined as the date of decrease in WHO scale compared to Baseline by at least 1 point - study drug administration date or date of discharge from hospital - study drug administration date, whichever occurred first. In the case that a participant did not reach an improvement, the participant was censored at end of study date.
Outcome measures
| Measure |
Efzofitimod 1 mg/kg
n=10 Participants
Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1.
|
Efzofitimod 3 mg/kg
n=12 Participants
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
n=10 Participants
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Time to Improvement From Inpatient Hospital Admission Based on at Least a 1-Point Reduction in WHO Ordinal Scale Score
|
5.0 days
Interval 1.0 to 10.0
|
4.0 days
Interval 2.0 to 6.0
|
3.0 days
Interval 1.0 to 5.0
|
Adverse Events
Efzofitimod 1 mg/kg
Serious events: 5 serious events
Other events: 8 other events
Deaths: 2 deaths
Efzofitimod 3 mg/kg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Efzofitimod 1 mg/kg
n=10 participants at risk
Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1.
|
Efzofitimod 3 mg/kg
n=12 participants at risk
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
n=10 participants at risk
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Infections and infestations
Septic shock
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Infections and infestations
Urosepsis
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Cardiac disorders
Acute myocardial infarction
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
Other adverse events
| Measure |
Efzofitimod 1 mg/kg
n=10 participants at risk
Participants received single dose of efzofitimod 1 mg/kg IV infusion on Day 1.
|
Efzofitimod 3 mg/kg
n=12 participants at risk
Participants received single dose of efzofitimod 3 mg/kg IV infusion on Day 1.
|
Placebo
n=10 participants at risk
Participants received placebo matched to efzofitimod IV infusion on Day 1.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Cardiac disorders
Tachycardia
|
20.0%
2/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Blood urea increased
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Blood chloride decreased
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Blood potassium decreased
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Blood sodium decreased
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Carbon dioxide increased
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Haemoglobin increased
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Hepatitis B virus test positive
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
N-terminal prohormone brain natriuretic peptide increased
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Platelet count increased
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Prothrombin time ratio increased
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Infections and infestations
Pneumonia streptococcal
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Eye disorders
Dry eye
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
8.3%
1/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
0.00%
0/12 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
10.0%
1/10 • Baseline up to Day 60
Safety Set was defined as all randomized participants who received any amount of study drug. Participants were summarized and analyzed 'as treated' (that is, by actual treatment group).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place