Trial Outcomes & Findings for MP1032 Treatment in Patients With Moderate to Severe COVID-19 (NCT NCT04932941)

NCT ID: NCT04932941

Last Updated: 2023-06-29

Results Overview

Disease progression was defined as the percentage of participants who were not alive or who had respiratory failure. Respiratory failure was defined as participants who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 132 participants
• Primary outcome timeframe: At Day 14
• Results posted on: 2023-06-29

Participant Flow

The study was conducted at 20 sites in 6 countries from 19 October 2021 to 05 September 2022. Participants were randomized in the 2:1 ratio to treatment groups using an Interactive Web Response System (IWRS).

A total of 134 participants were screened, of which 132 participants were randomized to either the MP1032 plus standard of care (SoC) group or the placebo plus SoC group.

Participant milestones

Measure	MP1032 300mg + SoC Participants received MP1032, 300 milligrams (mg) hard gelatin capsules orally, twice daily (BID) with hospital selected SoC procedure for 28 days.	Placebo + SoC Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Overall Study STARTED	87	45
Overall Study Intention-to-Treat Set (ITT)	87	45
Overall Study Pharmacokinetic Analysis Set	4	0
Overall Study Safety Set	86	45
Overall Study COMPLETED	73	38
Overall Study NOT COMPLETED	14	7

Reasons for withdrawal

Measure	MP1032 300mg + SoC Participants received MP1032, 300 milligrams (mg) hard gelatin capsules orally, twice daily (BID) with hospital selected SoC procedure for 28 days.	Placebo + SoC Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Overall Study Lost to Follow-up	3	1
Overall Study Withdrawal by Subject	7	4
Overall Study Other	4	2

Baseline Characteristics

MP1032 Treatment in Patients With Moderate to Severe COVID-19

Baseline characteristics by cohort

Measure	MP1032 300mg + SoC n=87 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=45 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Total n=132 Participants Total of all reporting groups
Age, Continuous	59.6 years STANDARD_DEVIATION 13.83 • n=5 Participants	62.3 years STANDARD_DEVIATION 14.15 • n=7 Participants	60.5 years STANDARD_DEVIATION 13.94 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	19 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	26 Participants n=7 Participants	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=5 Participants	44 Participants n=7 Participants	123 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	87 Participants n=5 Participants	45 Participants n=7 Participants	132 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 14

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Disease progression was defined as the percentage of participants who were not alive or who had respiratory failure. Respiratory failure was defined as participants who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.

Outcome measures

Measure	MP1032 300mg + SoC n=82 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=43 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Percentage of Participants With Disease Progression Using National Institute of Allergy and Infectious Diseases (NIAID) 8-point Ordinal Scale at Day 14	9.8 percentage of participants Interval 4.307 to 18.321	11.6 percentage of participants Interval 3.885 to 25.083

SECONDARY outcome

Timeframe: At Day 28

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Disease progression was defined as the percentage of participants who were not alive or who had respiratory failure. Respiratory failure was defined as participants who had a score of 2, 3 or 4 on the NIAID 8-point ordinal scale: The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.

Outcome measures

Measure	MP1032 300mg + SoC n=79 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=41 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Percentage of Participants With Disease Progression Using NIAID 8-point Ordinal Scale at Day 28	2.5 percentage of participants Interval 0.308 to 8.848	2.4 percentage of participants Interval 0.062 to 12.855

SECONDARY outcome

Timeframe: At Day 28

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Disease resolution was defined as participants who were alive and had a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.

Outcome measures

Measure	MP1032 300mg + SoC n=79 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=41 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Percentage of Participants With Disease Resolution at Day 28	97.5 percentage of participants Interval 91.152 to 99.692	97.6 percentage of participants Interval 87.145 to 99.938

SECONDARY outcome

Timeframe: Up to Day 28

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

All-cause mortality rate was the percentage of participants in each treatment group who died by Day 28 were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=82 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=42 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
All-cause Mortality Rate up to Day 28	2.4 percentage of participants Interval 0.297 to 8.534	2.4 percentage of participants Interval 0.06 to 12.566

SECONDARY outcome

Timeframe: Baseline, Day 28

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study.

The NIAID 8-point Ordinal Scale is an assessment of the clinical status on a given study day and the scale was defined as follows: 1=Death, 2=Hospitalized, on invasive ventilation (mechanical ventilator and/or ECMO), 3=Hospitalized, on non-invasive ventilation or high-flow oxygen devices, 4=Hospitalized, requiring supplemental oxygen, 5=Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (COVID-19 related or otherwise), 6=Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care (used if hospitalization was extended for infection-control reasons), 7=Not hospitalized, limitation on activities, and/or requiring home oxygen, 8=Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.

Outcome measures

Measure	MP1032 300mg + SoC n=87 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=45 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 28	3.542 score on a scale Standard Error 0.130	3.612 score on a scale Standard Error 0.174

SECONDARY outcome

Timeframe: At Day 14

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Disease resolution was defined as participants who were alive and had a score of 6, 7, or 8 on the NIAID 8-point ordinal scale. The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.

Outcome measures

Measure	MP1032 300mg + SoC n=82 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=43 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Percentage of Participants With Disease Resolution at Day 14	84.1 percentage of participants Interval 74.417 to 91.28	72.1 percentage of participants Interval 56.331 to 84.671

SECONDARY outcome

Timeframe: Up to Day 14 and Day 60

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoint.

The percentage of participants who died by Day 14 and Day 60 were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=83 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=43 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
All-cause Mortality Rate up to Day 14 and Day 60 Day 14	1.2 percentage of participants Interval 0.03 to 6.531	2.3 percentage of participants Interval 0.059 to 12.289
All-cause Mortality Rate up to Day 14 and Day 60 Day 60	3.8 percentage of participants Interval 0.78 to 10.57	4.9 percentage of participants Interval 0.596 to 16.533

SECONDARY outcome

Timeframe: Baseline, Day 14

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. The change from baseline in NIAID clinical status score related to COVID-19 at Day 14 were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=82 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=43 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Change From Baseline in Clinical Status Score Related to COVID-19 According to the NIAID 8-point Ordinal Scale at Day 14	2.987 score on a scale Standard Error 0.174	2.543 score on a scale Standard Error 0.242

SECONDARY outcome

Timeframe: At Day 14 and Day 28

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

Percentage of participants who required invasive mechanical ventilation/ECMO or who died by Day 14 and Day 28 were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=82 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=43 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28 Day 14	1.2 percentage of participants Interval 0.031 to 6.608	2.3 percentage of participants Interval 0.059 to 12.289
Percentage of Participants Who Required Invasive Ventilation (Mechanical Ventilator and/ ECMO), or Who Died at Day 14 and Day 28 Day 28	2.5 percentage of participants Interval 0.308 to 8.848	2.4 percentage of participants Interval 0.062 to 12.855

SECONDARY outcome

Timeframe: Baseline up to Day 60

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status. The change from baseline in NIAID clinical status score at each visit were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=86 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=44 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 2	0.1 score on a scale Standard Deviation 0.42	0.0 score on a scale Standard Deviation 0.21
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 5	0.4 score on a scale Standard Deviation 0.88	0.3 score on a scale Standard Deviation 0.70
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 6	0.6 score on a scale Standard Deviation 1.01	0.4 score on a scale Standard Deviation 0.76
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 7	1.2 score on a scale Standard Deviation 1.44	1.0 score on a scale Standard Deviation 1.34
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 11	2.3 score on a scale Standard Deviation 1.65	1.9 score on a scale Standard Deviation 1.82
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 12	2.5 score on a scale Standard Deviation 1.66	1.9 score on a scale Standard Deviation 1.82
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 13	2.7 score on a scale Standard Deviation 1.64	2.2 score on a scale Standard Deviation 1.71
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 14	3.0 score on a scale Standard Deviation 1.47	2.6 score on a scale Standard Deviation 1.72
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 28	3.7 score on a scale Standard Deviation 0.89	3.7 score on a scale Standard Deviation 0.51
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 60	3.7 score on a scale Standard Deviation 1.01	3.8 score on a scale Standard Deviation 0.49
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 8	1.6 score on a scale Standard Deviation 1.60	1.6 score on a scale Standard Deviation 1.75
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 9	2.0 score on a scale Standard Deviation 1.70	1.7 score on a scale Standard Deviation 1.77
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 10	2.2 score on a scale Standard Deviation 1.69	1.7 score on a scale Standard Deviation 1.83
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 3	0.2 score on a scale Standard Deviation 0.73	0.1 score on a scale Standard Deviation 0.46
Change From Baseline in Clinical Status Score of the NIAID 8-point Ordinal Scale at Each Visit Day 4	0.2 score on a scale Standard Deviation 0.83	0.2 score on a scale Standard Deviation 0.53

SECONDARY outcome

Timeframe: Baseline up to Day 28

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. As the table refers to "time to improvement', here, "Overall Number of Participants Analyzed" only signifies participants with at least 1 NIAID category of improvement at any time up to Day 28.

The NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Participants who did not improve at least 1 category on the NIAID scale or died before Day 28 were censored at Day 28. The total score range was 1 to 8 where, higher score indicates improvement in the clinical status.

Outcome measures

Measure	MP1032 300mg + SoC n=81 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=40 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Time to (First) Improvement of at Least 1 Category on the NIAID 8-point Ordinal Scale	7 days Interval 7.0 to 8.0	7 days Interval 6.0 to 8.0

SECONDARY outcome

Timeframe: Baseline, Day 14 and Day 28

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Number Analyzed" signifies participants for whom NIAID data were available for Day 14 and Day 28, respectively.

NIAID scale is an assessment of clinical status on a given study day and was defined as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Higher score = improvement in clinical status. Percentage of Participants with Clinical Status Improvement of at least 1 category from baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28 were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=87 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=45 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Percentage of Participants With Clinical Status Improvement of at Least 1 Category From Baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28 Day 14	90.2 percentage of participants	86.0 percentage of participants
Percentage of Participants With Clinical Status Improvement of at Least 1 Category From Baseline on the NIAID 8-point Ordinal Scale at Day 14 and Day 28 Day 28	98.7 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Day 28 and Day 60

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

Time to discharge i.e., the total duration of participant hospitalization from baseline to discharge at Day 28 and Day 60 was reported.

Outcome measures

Measure	MP1032 300mg + SoC n=83 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=42 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Time to Discharge by Day 28 and Day 60 Day 28	9 days Interval 8.0 to 10.0	10 days Interval 8.0 to 13.0
Time to Discharge by Day 28 and Day 60 Day 60	9 days Interval 8.0 to 10.0	10 days Interval 8.0 to 13.0

SECONDARY outcome

Timeframe: At Day 14, Day 28 and Day 60

Population: The ITT Set corresponded with the randomized set and included all randomized participants, irrespective of any deviation from the protocol or premature discontinuation from the study drug or withdrawal from study. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

Percentage of participants who were alive and tested negative for COVID-19 at Day 14, Day 28, and Day 60 were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=76 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=39 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 Day 14	67.1 percentage of participants Interval 55.374 to 77.457	66.7 percentage of participants Interval 49.783 to 80.912
Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 Day 28	91.3 percentage of participants Interval 82.028 to 96.742	92.1 percentage of participants Interval 78.623 to 98.341
Percentage of Participants Who Were Alive and Tested Negative for COVID-19 at Day 14, Day 28, and Day 60 Day 60	95.5 percentage of participants Interval 87.467 to 99.067	93.5 percentage of participants Interval 78.578 to 99.209

SECONDARY outcome

Timeframe: Day 1 up to Day 60

Population: The Safety Set included all randomized participants who received at least 1 dose of study drug.

An Adverse Event (AE) was any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at screening, worsens during the study, regardless of the suspected cause of the event. TEAE was defined as any adverse event which starts or worsens at any time after initiation of study drug until the end of the follow-up period at Day 60. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Number of participants with TEAEs and Serious TEAEs were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=86 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=45 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Participants with TEAEs	46 Participants	26 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Participants with Serious TEAEs	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Day 1 up to Day 60

Population: The Safety Set included all randomized participants who received at least 1 dose of study drug.

Vital sign parameters included of systolic and diastolic blood pressure, heart rate, respiration rate, oxygen saturation (SpO2), and body temperature. Any clinically significant change in vital signs were judged by the investigator. Number of participants with clinically significant change in vital sign values were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=86 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=45 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Number of Participants With Clinically Significant Change in Vital Sign	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline up to Day 60

Population: The Safety Set included all randomized participants who received at least 1 dose of study drug. Here, "Overall number of Participants Analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable at specified timepoints.

Physical examination included examination of respiratory, cardiovascular, dermatological, neurological, and gastrointestinal system. Any clinically significant abnormalities in physical examination were judged by the investigator. Number of participants with clinically significant abnormalities in physical examinations findings were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=86 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=45 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Abdomen- Day 8	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Cardiovascular- Baseline	4 Participants	2 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Abdomen- Baseline	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Cardiovascular-Day 8	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Cardiovascular-Day 14	2 Participants	0 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Head, Eyes, Ears, Nose, and Throat- Baseline	8 Participants	7 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Head, Eyes, Ears, Nose, and Throat- Day 8	0 Participants	2 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Head, Eyes, Ears, Nose, and Throat- Day 14	0 Participants	2 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Neurologic- Baseline	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Neurologic- Day 14	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Other- Baseline	14 Participants	8 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Other- Day 8	1 Participants	2 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Other- Day 14	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Respiratory- Baseline	38 Participants	22 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Respiratory- Day 8	4 Participants	2 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Respiratory- Day 14	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormalities in Physical Examinations Body System: Dermatologic- Baseline	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline up to Day 60

Population: The Safety Set included all randomized participants who received at least 1 dose of study drug.

Clinical laboratory tests included biochemistry, hematology and urinalysis. Any clinically significant abnormalities in clinical laboratory results were judged by the investigator. Number of participants with clinically significant abnormalities in laboratory results were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=86 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=45 Participants Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Results	23 Participants	22 Participants

SECONDARY outcome

Timeframe: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7

Population: The Pharmacokinetic (PK) Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "number analyzed" signifies participants who were evaluable at a specified timepoint.

Cmax of MP1032 in plasma were reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Measure	MP1032 300mg + SoC n=4 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Maximum Observed Plasma Concentration (Cmax) of MP1032 Day 1	284.15 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 170.38	—
Maximum Observed Plasma Concentration (Cmax) of MP1032 Day 7	279.29 nanograms per millilitre (ng/mL) Geometric Coefficient of Variation 37.85	—

SECONDARY outcome

Timeframe: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7

Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "number analyzed" signifies participants who were evaluable at a specified timepoints.

AUC0-t of MP1032 in plasma were reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.

Outcome measures

Measure	MP1032 300mg + SoC n=4 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032 Day 1	350.40 hour*nanograms per millilitre (h*ng/mL) Geometric Coefficient of Variation 42.87	—
Area Under the Plasma Concentration-time Curve From Time Zero to Last Non-zero Concentration (AUC0-t) of MP1032 Day 7	251.24 hour*nanograms per millilitre (h*ng/mL) Geometric Coefficient of Variation 28.72	—

SECONDARY outcome

Timeframe: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1

Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose.

Kel was calculated using negative of the estimated slope of the linear regression of the ln-transformed plasma concentration versus time profile in the terminal elimination phase. Kel of MP1032 in plasma were reported.

Outcome measures

Measure	MP1032 300mg + SoC n=4 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Apparent Elimination Rate Constant (Kel) of MP1032	0.7162 Per hour (1/h) Standard Deviation 0.8851	—

SECONDARY outcome

Timeframe: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1

Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Cl/F was estimated as Dose/AUC0-inf. CL/F of MP1032 in plasma was reported.

Outcome measures

Measure	MP1032 300mg + SoC n=3 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Apparent Body Clearance (CL/F) of MP1032	625.05 liter per hour (l/h) Geometric Coefficient of Variation 26.09	—

SECONDARY outcome

Timeframe: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1

Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.

Vz/F was estimated as Dose/(Kel x AUC0-inf). Vz/F of MP1032 in plasma was reported.

Outcome measures

Measure	MP1032 300mg + SoC n=3 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Apparent Volume of Distribution (Vz/F) of MP1032	1494.56 liter Geometric Coefficient of Variation 130.81	—

SECONDARY outcome

Timeframe: Pre-dose concentration (Day 2, Day 7, and Day 8).

Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "number analyzed" signifies participants who were evaluable at specified timepoints.

Ctrough of MP1032 in plasma was reported.

Outcome measures

Measure	MP1032 300mg + SoC n=4 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032 Day 2	9.74 ng/ml Standard Deviation 11.27	—
Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032 Day 7	60.79 ng/ml Standard Deviation 121.59	—
Plasma Concentration Prior to the Next Dose (Ctrough) of MP1032 Day 8	66.67 ng/ml Standard Deviation 115.48	—

SECONDARY outcome

Timeframe: Pre-dose, 0.16, 0.33, 0.5, 1, 2, 8 and 24 hours post-dose at Day 1 and Day 7

Population: The PK Analysis Set included all the participants who were administered active study drug and had at least 1 post-dose evaluable plasma concentration after Day 1 dose. Here, "number analyzed" signifies participants who were evaluable at a specified timepoints.

Average observed plasma concentration at steady state of MP1032 was reported.

Outcome measures

Measure	MP1032 300mg + SoC n=4 Participants Participants received MP1032, 300mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Average Observed Plasma Concentration at Steady State of MP1032 Day 1: pre-dose	0 ng/ml Geometric Coefficient of Variation 0	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 1: 0.16 hours post-dose	175.7 ng/ml Geometric Coefficient of Variation 322.8	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 1: 0.33 hours post-dose	200.1 ng/ml Geometric Coefficient of Variation 84.6	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 1: 0.5 hours post-dose	140.4 ng/ml Geometric Coefficient of Variation 55.3	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 1: 1 hour post-dose	64.39 ng/ml Geometric Coefficient of Variation 34.5	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 1: 2 hours post-dose	28.55 ng/ml Geometric Coefficient of Variation 145.5	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 1: 8 hours post-dose	15.48 ng/ml Geometric Coefficient of Variation 29.7	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 1: 24 hours post-dose	19.45 ng/ml Geometric Coefficient of Variation 7.5	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 7: pre-dose	243.2 ng/ml Geometric Coefficient of Variation 0	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 7: 0.33 hours post-dose	281.5 ng/ml Geometric Coefficient of Variation 55.4	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 7: 8 hours post-dose	NA ng/ml Geometric Coefficient of Variation NA At 8 hours geomean and CV% data was not estimated due to below limit of quantification (BLOQ).	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 7: 24hours post-dose	200.0 ng/ml Geometric Coefficient of Variation 0	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 7: 0.16 hours post-dose	187.3 ng/ml Geometric Coefficient of Variation 53.3	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 7: 0.5 hours post-dose	178.8 ng/ml Geometric Coefficient of Variation 41.1	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 7: 1 hour post-dose	94.42 ng/ml Geometric Coefficient of Variation 117.8	—
Average Observed Plasma Concentration at Steady State of MP1032 Day 7: 2 hours post-dose	79.55 ng/ml Geometric Coefficient of Variation 155.0	—

Adverse Events

MP1032 300mg + SoC

Serious events: 5 serious events

Other events: 46 other events

Deaths: 3 deaths

Placebo + SoC

Serious events: 3 serious events

Other events: 26 other events

Deaths: 2 deaths

Serious adverse events

Measure	MP1032 300mg + SoC n=86 participants at risk Participants received MP1032 300 mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=45 participants at risk Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.5% 3/86 • Number of events 3 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Number of events 1 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	1.2% 1/86 • Number of events 1 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations COVID-19	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	4.4% 2/45 • Number of events 2 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Pneumonia	1.2% 1/86 • Number of events 1 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
General disorders Multiple organ dysfunction syndrome	1.2% 1/86 • Number of events 1 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	1.2% 1/86 • Number of events 1 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.

Other adverse events

Measure	MP1032 300mg + SoC n=86 participants at risk Participants received MP1032 300 mg hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.	Placebo + SoC n=45 participants at risk Participants received placebo matched to MP1032 hard gelatin capsules orally, BID with hospital selected SoC procedure for 28 days.
Investigations Alanine aminotransferase increased	8.1% 7/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	13.3% 6/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Gamma-glutamyltransferase increased	4.7% 4/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	4.4% 2/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Aspartate aminotransferase increased	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	4.4% 2/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Blood glucose increased	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	6.7% 3/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Blood pressure increased	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Blood alkaline phosphatase increased	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Blood bilirubin increased	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Blood creatinine increased	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	4.4% 2/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Activated partial thromboplastin time shortened	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Blood pressure systolic increased	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Blood triglycerides increased	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Intestinal transit time increased	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Investigations Transaminases increased	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Metabolism and nutrition disorders Hypertriglyceridaemia	10.5% 9/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	8.9% 4/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Metabolism and nutrition disorders Hyperglycaemia	3.5% 3/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	8.9% 4/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Metabolism and nutrition disorders Hypercholesterolaemia	3.5% 3/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	4.4% 2/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Metabolism and nutrition disorders Hypophosphataemia	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Metabolism and nutrition disorders Hypoglycaemia	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Metabolism and nutrition disorders Hypokalaemia	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Metabolism and nutrition disorders Fluid overload	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Gastrointestinal disorders Diarrhoea	5.8% 5/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Gastrointestinal disorders Abdominal pain	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	4.4% 2/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Gastrointestinal disorders Nausea	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Gastrointestinal disorders Dry mouth	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Gastrointestinal disorders Abdominal discomfort	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Gastrointestinal disorders Constipation	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Gastrointestinal disorders Dyspepsia	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Gastrointestinal disorders Dysphagia	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Gastrointestinal disorders Food poisoning	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Gastrointestinal disorders Vomiting	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Clostridium difficile infection	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Toxic shock syndrome	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Bronchitis bacterial	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations COVID-19	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Clostridium difficile colitis	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Conjunctivitis	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Escherichia urinary tract infection	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations HIV infection	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Hepatic infection	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Infection	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Oral candidiasis	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Oral herpes	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Pneumonia	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Infections and infestations Urinary tract infection	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Cardiac disorders Bradycardia	4.7% 4/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	4.4% 2/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Cardiac disorders Atrial fibrillation	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Blood and lymphatic system disorders Leukocytosis	3.5% 3/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Blood and lymphatic system disorders Neutrophilia	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Blood and lymphatic system disorders Thrombocytosis	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Blood and lymphatic system disorders Blood disorder	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Blood and lymphatic system disorders Normochromic normocytic anaemia	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
General disorders Pyrexia	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
General disorders Asthenia	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
General disorders Chest discomfort	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
General disorders Chest pain	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Ear and labyrinth disorders Vertigo	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Ear and labyrinth disorders Tinnitus	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Nervous system disorders Disturbance in attention	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Nervous system disorders Headache	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Nervous system disorders Tremor	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Skin and subcutaneous tissue disorders Hand dermatitis	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Skin and subcutaneous tissue disorders Rash	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Skin and subcutaneous tissue disorders Urticaria	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Vascular disorders Hypertension	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Vascular disorders Cyanosis	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Hepatobiliary disorders Hepatic cytolysis	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Hepatobiliary disorders Hepatitis toxic	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Immune system disorders Drug hypersensitivity	2.3% 2/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Psychiatric disorders Emotional disorder	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Psychiatric disorders Insomnia	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Renal and urinary disorders Acute kidney injury	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Renal and urinary disorders Haematuria	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Endocrine disorders Hypothyroidism	1.2% 1/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	0.00% 0/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Eye disorders Cataract	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.
Eye disorders Ulcerative keratitis	0.00% 0/86 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.	2.2% 1/45 • Baseline up to Day 60 Reported AEs are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 60 days). For the overview on serious AEs, other AEs and all-Cause Mortality, data were collected and evaluated during the study for Safety Population Set only (i.e, all randomized participants who received at least 1 dose of study drug). Surgical procedures that were planned before the participant was randomized in the study are not considered AEs.

Additional Information

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