Trial Outcomes & Findings for Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19) (NCT NCT04341116)

NCT ID: NCT04341116

Last Updated: 2023-05-06

Results Overview

Free of mechanical ventilation was defined as proportion of subjects who scores 1 to 5 in the following 8-category ordinal scale. 8, death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4, hospitalization with oxygen by mask or nasal prongs; 3. Hospitalization without oxygen supplementation; 2, limitation of activities, discharge from hospital; and 1, no limitation of activities, discharge from hospital.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 149 participants
• Primary outcome timeframe: Day 1 through Day 30
• Results posted on: 2023-05-06

Participant Flow

Participant milestones

Measure	TJ003234 3mg/kg (Part 1) Subjects treated with 3mg/kg of TJ003234	TJ003234 6mg/kg (Part 1) Subjects treated with 6mg/kg TJ003234	Placebo (Part 1) Subjects treated with placebo in Part 1	TJ003234 6mg/kg (Part 2) Subjects treated with 6mg/kg in Part 2	TJ003234 10mg/kg (Part 2) Subjects treated with 10mg/kg of TJ003234	Placebo (Part 2) Subjects treated with placebo in Part 2
Overall Study STARTED	8	8	8	77	6	42
Overall Study COMPLETED	7	6	6	66	5	34
Overall Study NOT COMPLETED	1	2	2	11	1	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19)

Baseline characteristics by cohort

Measure	TJ003234 3mg/kg (Part 1) n=8 Participants subjects treated by 3mg/kg of TJ003234	TJ003234 6mg/kg (Part 1) n=8 Participants subjects treated by 6mg/kg of TJ003234 in Part 1	Placebo (Part 1) n=8 Participants subjects treated by placebo in Part 1	TJ003234 6mg/kg (Part 2) n=77 Participants subjects treated by 6mg/kg of TJ003234 in Part 2	TJ003234 10mg/kg (Part 2) n=6 Participants subjects treated by 10 mg/kg of TJ003234 in Part 2	Placebo (Part 2) n=42 Participants subjects treated by placebo in Part 2	Total n=149 Participants Total of all reporting groups
Age, Continuous	51.9 years n=5 Participants	58.4 years n=7 Participants	58 years n=5 Participants	55.6 years n=4 Participants	57.2 years n=21 Participants	56.4 years n=8 Participants	56 years n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	49 Participants n=4 Participants	4 Participants n=21 Participants	24 Participants n=8 Participants	88 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	28 Participants n=4 Participants	2 Participants n=21 Participants	18 Participants n=8 Participants	61 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	33 Participants n=4 Participants	2 Participants n=21 Participants	16 Participants n=8 Participants	53 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	44 Participants n=4 Participants	4 Participants n=21 Participants	26 Participants n=8 Participants	96 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	23 Participants n=4 Participants	3 Participants n=21 Participants	10 Participants n=8 Participants	46 Participants n=8 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	39 Participants n=4 Participants	3 Participants n=21 Participants	21 Participants n=8 Participants	77 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	11 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants	17 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	77 participants n=4 Participants	6 participants n=21 Participants	42 participants n=8 Participants	149 participants n=8 Participants
Height	168.8 cm n=5 Participants	166.8 cm n=7 Participants	173.3 cm n=5 Participants	167.1 cm n=4 Participants	171.0 cm n=21 Participants	168.3 cm n=8 Participants	168.65 cm n=8 Participants
Weight	101.4 kg n=5 Participants	88.0 kg n=7 Participants	108.9 kg n=5 Participants	97.2 kg n=4 Participants	98.1 kg n=21 Participants	97.1 kg n=8 Participants	98.3 kg n=8 Participants
Mechanical Ventilation Yes	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=8 Participants	25 Participants n=8 Participants
Mechanical Ventilation No	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	67 Participants n=4 Participants	6 Participants n=21 Participants	36 Participants n=8 Participants	115 Participants n=8 Participants
Mechanical Ventilation Unknown	2 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	9 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 30

Population: All subjects randomized to treatment who were mechanical ventilation free at baseline was collected only for Part 2 arms/groups. Data was not collected from the Part 1 Arms/Groups.

Free of mechanical ventilation was defined as proportion of subjects who scores 1 to 5 in the following 8-category ordinal scale.

8, death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4, hospitalization with oxygen by mask or nasal prongs; 3. Hospitalization without oxygen supplementation; 2, limitation of activities, discharge from hospital; and 1, no limitation of activities, discharge from hospital.

Outcome measures

Measure	TJ003234 6mg/kg (Part 1) subjects treated with TJ003234 6mg/kg -Part 1	Placebo (Part 1) subjects treated with placebo (Part 1)	TJ003234 6mg/kg (Part 2) n=67 Participants subjects treated with TJ003234 6mg/kg (mITT population)	TJ0032034 10mg/kg (Part 2) n=6 Participants subjects treated with TJ003234 10mg/kg (mITT population)	Placebo (Part 2) n=36 Participants Subjects treated with placebo (mITT population)
Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline	—	—	56 Participants	5 Participants	27 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 14

Population: All subjects randomized was collected only for Part 2 arms/groups. Data was not collected from the Part 1 Arms/Groups.

Sustained recovery in clinical status was defined as patients who have hospitalization without oxygen supplement or discharge from hospital.

Outcome measures

Measure	TJ003234 6mg/kg (Part 1) subjects treated with TJ003234 6mg/kg -Part 1	Placebo (Part 1) subjects treated with placebo (Part 1)	TJ003234 6mg/kg (Part 2) n=77 Participants subjects treated with TJ003234 6mg/kg (mITT population)	TJ0032034 10mg/kg (Part 2) n=6 Participants subjects treated with TJ003234 10mg/kg (mITT population)	Placebo (Part 2) n=42 Participants Subjects treated with placebo (mITT population)
Percentage of Recovery by Day 14	—	—	47 Participants	5 Participants	20 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 30

Population: All subjects randomized was collected only for Part 2 arms/groups. Data was not collected from the Part 1 Arms/Groups.

Sustained recovery in clinical status was defined as patients who have hospitalization without oxygen supplement or discharge from hospital.

Outcome measures

Measure	TJ003234 6mg/kg (Part 1) subjects treated with TJ003234 6mg/kg -Part 1	Placebo (Part 1) subjects treated with placebo (Part 1)	TJ003234 6mg/kg (Part 2) n=77 Participants subjects treated with TJ003234 6mg/kg (mITT population)	TJ0032034 10mg/kg (Part 2) n=6 Participants subjects treated with TJ003234 10mg/kg (mITT population)	Placebo (Part 2) n=42 Participants Subjects treated with placebo (mITT population)
Percentage of Subjects Recovered on Day 30	—	—	56 Participants	5 Participants	27 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 30

Population: All subjects randomized was collected only for Part 2 arms/groups. Data was not collected from the Part 1 Arms/Groups.

The percentage of subjects who deceased by any cause.

Outcome measures

Measure	TJ003234 6mg/kg (Part 1) subjects treated with TJ003234 6mg/kg -Part 1	Placebo (Part 1) subjects treated with placebo (Part 1)	TJ003234 6mg/kg (Part 2) n=77 Participants subjects treated with TJ003234 6mg/kg (mITT population)	TJ0032034 10mg/kg (Part 2) n=6 Participants subjects treated with TJ003234 10mg/kg (mITT population)	Placebo (Part 2) n=42 Participants Subjects treated with placebo (mITT population)
All-cause Mortality Rate by Day 30	—	—	7 Participants	1 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 30

Population: All subjects randomized without mechanical ventilation Part 2. Part 1 is designed as a randomized, double-blind, placebo-controlled, 3-arm, parallel-group study to evaluate the safety of plonmarlimab in subjects with severe COVID-19. So, no available efficacy data for this part.

Time to sustained recovery

Outcome measures

Measure	TJ003234 6mg/kg (Part 1) subjects treated with TJ003234 6mg/kg -Part 1	Placebo (Part 1) subjects treated with placebo (Part 1)	TJ003234 6mg/kg (Part 2) n=67 Participants subjects treated with TJ003234 6mg/kg (mITT population)	TJ0032034 10mg/kg (Part 2) n=6 Participants subjects treated with TJ003234 10mg/kg (mITT population)	Placebo (Part 2) n=36 Participants Subjects treated with placebo (mITT population)
Time to Recovery Among Subjects Alive by Day 30	—	—	8 days Interval 5.0 to 18.0	6.5 days Interval 4.0 to 10.0	10 days Interval 4.0 to 22.0

SECONDARY outcome

Timeframe: Day 1 through Day 30

Population: All subjects without mechanical ventilation- Part 2. Part 1 is designed as a randomized, double-blind, placebo-controlled, 3-arm, parallel-group study to evaluate the safety of plonmarlimab in subjects with severe COVID-19. So, no available efficacy data for this part.

Duration of hospitalization

Outcome measures

Measure	TJ003234 6mg/kg (Part 1) subjects treated with TJ003234 6mg/kg -Part 1	Placebo (Part 1) subjects treated with placebo (Part 1)	TJ003234 6mg/kg (Part 2) n=67 Participants subjects treated with TJ003234 6mg/kg (mITT population)	TJ0032034 10mg/kg (Part 2) n=6 Participants subjects treated with TJ003234 10mg/kg (mITT population)	Placebo (Part 2) n=36 Participants Subjects treated with placebo (mITT population)
Length of Hospitalization	—	—	10 days Interval 8.0 to 13.0	9.5 days Interval 1.0 to 12.0	11 days Interval 7.0 to 18.0

Adverse Events

TJ003234 3 mg/kg (Part 1)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

TJ003234 6mg/kg (Part 1)

Serious events: 4 serious events

Other events: 0 other events

Deaths: 1 deaths

Placebo (Part 1)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

TJ003234 6 mg/kg (Part 2)

Serious events: 22 serious events

Other events: 0 other events

Deaths: 11 deaths

TJ003234 10mg/kg (Part 2)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Placebo (Part 2)

Serious events: 16 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Measure	TJ003234 3 mg/kg (Part 1) n=8 participants at risk subjects treated with 3mg/kg TJ003234 (Part 1) (Safety population)	TJ003234 6mg/kg (Part 1) n=8 participants at risk subjects treated with 6 mg/kg TJ003234 (Safety population)	Placebo (Part 1) n=8 participants at risk subjects treated by placebo (Safety population)	TJ003234 6 mg/kg (Part 2) n=77 participants at risk subjects treated with 6mg/kg TJ003234 (Safety population)	TJ003234 10mg/kg (Part 2) n=6 participants at risk subjects treated with 10mg/kg (Safety population)	Placebo (Part 2) n=42 participants at risk subjects treated by placebo (Safety population)
Endocrine disorders ADRENAL INSUFFICIENCY	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Cardiac disorders Cardiac Arrest	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	12.5% 1/8 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.6% 2/77 • Number of events 2 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Cardiac disorders MYOCARDIAL ISCHEMIA	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Cardiac disorders WORSENING BRADYCARDIA	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Cardiac disorders TAKOTSUBO CARDIOMYOPATHY	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
General disorders MULTI ORGAN SYSTEM FAILURE	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Infections and infestations SEPTIC SHOCK	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	12.5% 1/8 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	7.8% 6/77 • Number of events 6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	9.5% 4/42 • Number of events 4 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Infections and infestations BACTEREMIA	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	5.2% 4/77 • Number of events 4 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Infections and infestations (Worsening) PNEUMONIA (due to COVID-19)	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	3.9% 3/77 • Number of events 3 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	16.7% 1/6 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Infections and infestations SEPSIS	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	4.8% 2/42 • Number of events 2 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Injury, poisoning and procedural complications SELF-EXTUBATION WITH COMPLICATION	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Nervous system disorders INTRACRANIAL HEMORRHAGIC TRANSFORMATION	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Nervous system disorders SUBARACHNOID HEMORRHAGE	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Renal and urinary disorders ACUTE KIDNEY INJURY	12.5% 1/8 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.6% 2/77 • Number of events 2 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	7.1% 3/42 • Number of events 3 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders (WORSENING) HYPOXIC RESPIRATORY FAILURE	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	16.9% 13/77 • Number of events 13 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	11.9% 5/42 • Number of events 5 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders (WORSENING) RESPIRATORY FAILURE DUE TO COVID-19	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	9.1% 7/77 • Number of events 7 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	9.5% 4/42 • Number of events 4 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.6% 2/77 • Number of events 2 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	4.8% 2/42 • Number of events 2 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders PULMONARY FIBROSIS	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders WORSENING BILATERAL PNEUMONITITS	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Skin and subcutaneous tissue disorders SUBCUTANEOUS EMPHYSEMA	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Vascular disorders DISTRIBUTIVE SHOCK	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Vascular disorders NECROTIC DIGITS	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Vascular disorders HEMORRHAGIC SHOCK	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	1.3% 1/77 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Cardiac disorders CARDIOGENIC SHOCK	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Cardiac disorders ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	4.8% 2/42 • Number of events 2 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Gastrointestinal disorders PNEUMOPERITONEUM	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Gastrointestinal disorders MELENA	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders HOSPITAL-ACQUIRED PNEUMONIA	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders VENTILATOR ASSOCIATED PNEUMONIA	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	4.8% 2/42 • Number of events 2 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders COVID-19 INDUCED MYOCARDITIS	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Injury, poisoning and procedural complications AVULSION OF RIGHT COMMON FEMORAL ARTERY	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Renal and urinary disorders ACUTE TUBULAR NECROSIS	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Vascular disorders RIGHT AXILLARY DEEP VEIN THROMBOSIS	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders PERSISTENT SHORTNESS OF BREATH	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	2.4% 1/42 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Infections and infestations COVID-19	12.5% 1/8 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	12.5% 1/8 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	12.5% 1/8 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	12.5% 1/8 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	12.5% 1/8 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	12.5% 1/8 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	12.5% 1/8 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.
Surgical and medical procedures Endotracheal intubation	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	12.5% 1/8 • Number of events 1 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/8 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/77 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/6 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.	0.00% 0/42 • All adverse events will be collected from the day of informed consent to Day 30. Disease progression or deterioration is also recorded as an AE/SAE, regardless of whether the Investigator assesses that it is related to the study drug. Signs and symptoms from the following may be considered AEs: drug overdose, withdrawal or misuse, drug interactions, extravasations, exposure during pregnancy/breastfeeding. Safety reporting results are based on ITT population.

Other adverse events

Adverse event data not reported

Additional Information

Claire Xu

I-Mab Biopharma US Ltd

Phone: 3177558242

Email: Claire.Xu@i-mabbiopharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place