Trial Outcomes & Findings for Losmapimod Safety and Efficacy in COVID-19 (NCT NCT04511819)

Last Updated: 2024-03-13

Results Overview

Respiratory failure was defined as either need for mechanical ventilation (invasive or non-invasive) or high flow oxygen (defined by greater than 15 liters per minute \[LPM\] flow of oxygen to maintain oxygen saturation between 90% and 95%), sustained for at least 48 hours, at any time during the study. The fitted logistic regression model was used to predict the response rate for every participant in the study who had received the treatment or the control intervention. The efficacy of Losmapimod was assessed by the development of progression to critical disease as evidence of mortality or development of respiratory failure by Day 28. Percentage of participants who progressed to death or respiratory failure by Day 28 has been presented.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

52 participants

Primary outcome timeframe

Up to Day 28

Results posted on

2024-03-13

Participant Flow

The study was conducted across 5 sites in the United States and 3 sites in Brazil.

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study which evaluated the safety and efficacy of losmapimod versus placebo on a background of standard of care in participants with Coronavirus disease-2019 (COVID-19) disease (LOSVID Study)

Participant milestones

Participant milestones
Measure	Placebo Participants were randomized to receive matching placebo tablets orally (PO) twice per day (BID) with food whenever possible and with 240 milliliters (mL) of room temperature water for 14 days.	Losmapimod 15 Milligrams (mg) Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose) PO BID with food whenever possible and with 240 mL of room temperature water for 14 days.
Overall Study STARTED	26	22
Overall Study COMPLETED	20	17
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants were randomized to receive matching placebo tablets orally (PO) twice per day (BID) with food whenever possible and with 240 milliliters (mL) of room temperature water for 14 days.	Losmapimod 15 Milligrams (mg) Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose) PO BID with food whenever possible and with 240 mL of room temperature water for 14 days.
Overall Study Non-compliance with study drug	5	1
Overall Study Withdrawal by Subject	0	3
Overall Study Adverse Event	0	1
Overall Study Protocol deviation	1	0

Baseline Characteristics

Losmapimod Safety and Efficacy in COVID-19

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=26 Participants Participants were randomized to receive matching placebo tablets orally (PO) twice per day (BID) with food whenever possible and with 240 milliliters (mL) of room temperature water for 14 days.	Losmapimod 15 Milligrams (mg) n=22 Participants Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose) PO BID with food whenever possible and with 240 mL of room temperature water for 14 days.	Total n=48 Participants Total of all reporting groups
Age, Continuous	57.7 Years STANDARD_DEVIATION 12.15 • n=5 Participants	60.8 Years STANDARD_DEVIATION 10.00 • n=7 Participants	59.1 Years STANDARD_DEVIATION 11.21 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants	16 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	12 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	5 Participants n=7 Participants	8 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: Up to Day 28

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants were randomized to receive matching placebo tablets orally (PO) twice per day (BID) with food whenever possible and with 240 milliliters (mL) of room temperature water for 14 days.	Losmapimod 15 Milligrams (mg) n=22 Participants Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose) PO BID with food whenever possible and with 240 mL of room temperature water for 14 days.
Percentage of Participants Who Progressed to Death or Respiratory Failure by Day 28	61.5 Percentage of participants	75.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and at Day 7 and Day 14

Population: Full Analysis Set. Only those participants with data available at the specified data points were analyzed.

Change in clinical status between Baseline and at Days 7 and 14 was modeled using ordinal logistic regression models, adjusting for stratification factors, sex and baseline C-reactive protein (CRP). WHO 9-point ordinal scale included score ranges as: 0:No clinical evidence of the disease, 1: Discharged from the hospital and without any limitation, 2: Discharged from the hospital but with limitation of activities, 3: Hospitalized but not requiring oxygen therapy, 4: Oxygen therapy but not requiring high-flow or non-invasive ventilation, 5: Noninvasive ventilation or high-flow oxygen therapy, 6: Intubation and mechanical ventilation, 7: Ventilation plus additional organ support and 8: Death. Higher scores indicated worse clinical status. Baseline was defined as the last measurement prior to the first dose of study drug. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Participants were randomized to receive matching placebo tablets orally (PO) twice per day (BID) with food whenever possible and with 240 milliliters (mL) of room temperature water for 14 days.	Losmapimod 15 Milligrams (mg) n=22 Participants Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose) PO BID with food whenever possible and with 240 mL of room temperature water for 14 days.
Change From Baseline in Clinical Status at Days 7 and 14 Assessed on the 9-point World Health Organization (WHO) Ordinal Scale Day 7	-1.6 Scores on a scale Standard Deviation 1.14	-1.4 Scores on a scale Standard Deviation 1.58
Change From Baseline in Clinical Status at Days 7 and 14 Assessed on the 9-point World Health Organization (WHO) Ordinal Scale Day 14	-2.2 Scores on a scale Standard Deviation 0.83	-2.0 Scores on a scale Standard Deviation 1.31

SECONDARY outcome

Timeframe: Up to Day 28

Population: Full Analysis Set. Only those participants with data available at the specified data points were analyzed.

A Poisson regression model or a negative binomial model was used to assess the relationship with treatment, adjusting for stratification factors, sex, baseline CRP and number of days on study (as applicable). Total number of study days free of oxygen supplementation has been presented.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants were randomized to receive matching placebo tablets orally (PO) twice per day (BID) with food whenever possible and with 240 milliliters (mL) of room temperature water for 14 days.	Losmapimod 15 Milligrams (mg) n=18 Participants Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose) PO BID with food whenever possible and with 240 mL of room temperature water for 14 days.
Total Number of Study Days Free of Oxygen Supplementation	24.0 Days Standard Deviation 3.52	20.6 Days Standard Deviation 8.80

SECONDARY outcome

Timeframe: At Day 28

Population: Full Analysis Set. Only those participants with data available at the specified data points were analyzed.

Percentage of participants who reported death have been presented.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants Participants were randomized to receive matching placebo tablets orally (PO) twice per day (BID) with food whenever possible and with 240 milliliters (mL) of room temperature water for 14 days.	Losmapimod 15 Milligrams (mg) n=16 Participants Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose) PO BID with food whenever possible and with 240 mL of room temperature water for 14 days.
Percentage of Participants Reporting All-cause Mortality at Day 28	0.0 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to Day 28

Population: Full Analysis Set. Only those participants with data available at the specified data points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants were randomized to receive matching placebo tablets orally (PO) twice per day (BID) with food whenever possible and with 240 milliliters (mL) of room temperature water for 14 days.	Losmapimod 15 Milligrams (mg) n=18 Participants Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose) PO BID with food whenever possible and with 240 mL of room temperature water for 14 days.
Number of Study Days Alive	27.9 Days Standard Deviation 0.27	27.8 Days Standard Deviation 0.51

SECONDARY outcome

Timeframe: Up to Day 28

Population: Safety Analysis Set: included all participants who received any study drug.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of participants with non-serious AEs and SAEs has been presented.

Outcome measures

Outcome measures
Measure	Placebo n=26 Participants Participants were randomized to receive matching placebo tablets orally (PO) twice per day (BID) with food whenever possible and with 240 milliliters (mL) of room temperature water for 14 days.	Losmapimod 15 Milligrams (mg) n=22 Participants Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose) PO BID with food whenever possible and with 240 mL of room temperature water for 14 days.
Number of Participants Reporting Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	0 Participants	4 Participants
Number of Participants Reporting Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) Non-serious AEs	15 Participants	12 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Losmapimod 15 Milligrams (mg)

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=26 participants at risk Participants were randomized to receive matching placebo tablets orally (PO) twice per day (BID) with food whenever possible and with 240 milliliters (mL) of room temperature water for 14 days.	Losmapimod 15 Milligrams (mg) n=22 participants at risk Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose) PO BID with food whenever possible and with 240 mL of room temperature water for 14 days.
Cardiac disorders Atrial fibrillation	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	9.1% 2/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Cardiac disorders Acute coronary syndrome	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.

Other adverse events

Additional Information

Call Center

Fulcrum Therapeutics

Phone: 617-651-8853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Placebo n=26 participants at risk Participants were randomized to receive matching placebo tablets orally (PO) twice per day (BID) with food whenever possible and with 240 milliliters (mL) of room temperature water for 14 days.	Losmapimod 15 Milligrams (mg) n=22 participants at risk Participants were randomized to receive losmapimod tablets 15 mg (2×7.5 mg tablets/dose) PO BID with food whenever possible and with 240 mL of room temperature water for 14 days.
Gastrointestinal disorders Constipation	7.7% 2/26 • Up to Day 28 Safety population which included all participants who received any study drug.	9.1% 2/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Diarrhoea	11.5% 3/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Vomiting	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Abdominal distension	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Gastric ulcer	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Gastritis	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Hiatus hernia	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Tongue discomfort	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Gastrointestinal disorders Tongue erythema	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
General disorders Non-cardiac chest pain	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	9.1% 2/22 • Up to Day 28 Safety population which included all participants who received any study drug.
General disorders Oedema peripheral	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
General disorders Chest discomfort	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
General disorders Chills	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
General disorders Fatigue	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Investigations Glucose urine present	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Investigations Blood glucose increased	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Investigations Electrocardiogram ST segment elevation	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Investigations Transaminases increased	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Investigations Urine analysis abnormal	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Investigations Weight decreased	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Investigations White blood cell count increased	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Psychiatric disorders Anxiety	7.7% 2/26 • Up to Day 28 Safety population which included all participants who received any study drug.	9.1% 2/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Psychiatric disorders Depression	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Psychiatric disorders Insomnia	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Psychiatric disorders Mental status changes	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	9.1% 2/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	9.1% 2/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Respiratory, thoracic and mediastinal disorders Cough	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Blood and lymphatic system disorders Anaemia	7.7% 2/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Blood and lymphatic system disorders Normocytic anaemia	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Blood and lymphatic system disorders Thrombocytosis	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Cardiac disorders Atrial fibrillation	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	9.1% 2/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Cardiac disorders Acute coronary syndrome	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Cardiac disorders Cardiac failure congestive	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Metabolism and nutrition disorders Metabolic acidosis	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Metabolism and nutrition disorders Hyperglycaemia	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Musculoskeletal and connective tissue disorders Back pain	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Infections and infestations COVID-19	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Infections and infestations Respiratory tract infection	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Nervous system disorders Dizziness	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Nervous system disorders Tension headache	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Renal and urinary disorders Acute kidney injury	0.00% 0/26 • Up to Day 28 Safety population which included all participants who received any study drug.	4.5% 1/22 • Up to Day 28 Safety population which included all participants who received any study drug.
Vascular disorders Phlebitis	3.8% 1/26 • Up to Day 28 Safety population which included all participants who received any study drug.	0.00% 0/22 • Up to Day 28 Safety population which included all participants who received any study drug.