Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID... | NCT04467840

Label	Type	Description	Intervention Names
Opaganib	Experimental	In addition to standard of care, opaganib will be administered orally with 2 x 250 mg capsules (500 mg) every 12 hours. When required this may be made into a suspension form and may be administered by nasogastric tube.	Drug: Opaganib
Placebo	Placebo Comparator	In addition to standard of care, a matching placebo will be administered orally with 2 x 250 mg capsules (500 mg) every 12 hours. Where required this may be made into a suspension form and may be administered by nasogastric tube.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Opaganib	Drug	Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).

Measure	Description	Time Frame
Supplemental Oxygen Requirement	To compare the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14 between subjects taking opaganib and those on placebo.	14 days maintained up to 42 days

Measure	Description	Time Frame
Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42	Compare ≥2 category improvement on the WHO Ordinal Scale for Clinical Improvement from 0(uninfected) to 8(death) for subjects taking opaganib and those on placebo, lower scores indicate improvement. Success was defined as subject who reached improvement of at least two points on the WHO Ordinal Scale by Day 14, maintained by the end of study visit, and failure otherwise.

Measure	Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	To compare the number of participants with treatment emergent adverse events (TEAEs) in patients with severe COVID-19 pneumonia between participants taking opaganib and participants taking placebo	From first dose until 4 weeks follow-up after the end of treatment

Name	Affiliation	Role
Mark L Levitt, MD	RedHill Biopharma Limited	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
ABC-201 Site 901		Detroit	Michigan	00000	United States
ABC-201 Site 408

ID	Title	Description
FG000	Opaganib	In addition to standard of care, opaganib will be administered orally with 2 x 250 mg capsules (500 mg) every 12 hours. When required this may be made into a suspension form and may be administered by nasogastric tube. Opaganib: Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 15, 2021	Dec 21, 2022

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Subjects not receiving supplemental oxygen for at least 24 hours by Day 14 and maintained at Day 42	OG000139 OG001132
Subjects receiving supplemental oxygen (including: death, lost to follow-up, or need of oxygen)	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		0.391	The threshold for statistical significance was p = 0.05	Risk Difference (RD)	3.86			2-Sided	95	-4.93	12.65			Opaganib - Placebo		Superiority

Secondary

Percentage of Subjects With ≥ 2 Category Improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42

Compare ≥2 category improvement on the WHO Ordinal Scale for Clinical Improvement from 0(uninfected) to 8(death) for subjects taking opaganib and those on placebo, lower scores indicate improvement. Success was defined as subject who reached improvement of at least two points on the WHO Ordinal Scale by Day 14, maintained by the end of study visit, and failure otherwise.

mITT

Posted

Count of Participants

Participants

14 days maintained up to 42 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units

Secondary

Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement With a Scale Ranging From 8 Down to 0

Compare scores of subjects taking opaganib and those on placebo, lower scores indicate improvement to determine time to recovery as defined by improvement to a score of 3 or less on the WHO Ordinal Scale for Clinical Improvement with a scale ranging from 0 (uninfected) to 8 (death)

mITT population presenting subjects who experienced a recovery event by Day 14 maintained up to day 42

Posted

Count of Participants

Participants

14 days maintained up to 42 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts

Secondary

Number of Participants With Low Oxygen Flow Via Nasal Cannula

To compare the time to low oxygen flow via nasal cannula e.g. from high oxygen flow via nasal cannula or CPAP, if high oxygen flow is not an available option between subjects taking opaganib and those on placebo.

mITT. In this analysis, subjects who required low-flow supplemental oxygen at Day 1 (baseline) were considered success events, and the time to event of interest for these subjects was defined as 0.

Posted

Count of Participants

Participants

14 days maintained up to 42 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts

Secondary

Time to Discharge From Hospital Measured at 14 Days

Time to subject discharge from hospital

mITT

Posted

Median

95% Confidence Interval

Days

14 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants	OG000

Secondary

Patients Requiring Intubation and Mechanical Ventilation by Day 42

To compare the proportion of patients requiring intubation and mechanical ventilation between subjects taking opaganib and those on placebo.

Subjects requiring intubation by Day 42

Posted

Count of Participants

Participants

42 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants	OG000

Secondary

Number of Patients With Two Consecutive Negative Swabs for SARS-CoV-2 at Day 14

To compare the number of patients with two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14 between subjects taking opaganib and those on placebo.

Only subjects who were positive for SARS-CoV-2 by PCR at the screening visit were analyzed

Posted

Number

participants

14 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Secondary

Patients With Negative Swabs for SARS-CoV-2 at Day 14

To compare the proportion of patients with two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14 between subjects taking opaganib and those on placebo.

Only subjects who were positive for SARS-CoV-2 by PCR at the screening visit AND had at least two post baseline PCR tests were analyzed.

Posted

Count of Participants

Participants

14 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Secondary

Mortality Due to Any Cause

To compare mortality 28 days post-baseline between subjects taking opaganib and those taking placebo

Mortality ("failure") was assessed by treatment Day 28 (including). Any early termination/ missing survival status at the end of study visit was also regarded as failure for the primary analysis of this endpoint.

Posted

Count of Participants

Participants

28 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Secondary

Mortality Due to Any Cause

To compare mortality 42 days post-baseline between subjects taking opaganib and those taking placebo

Mortality ("failure") was assessed by treatment Day 42 (including). Any early termination/ missing survival status at the end of study visit was also regarded as failure for the primary analysis of this endpoint.

Posted

Count of Participants

Participants

42 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Other Pre-specified

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

To compare the number of participants with treatment emergent adverse events (TEAEs) in patients with severe COVID-19 pneumonia between participants taking opaganib and participants taking placebo

TEAE=Treatment emergent adverse event. Treatment emergent events are events that started on or after the date of first dose

Posted

Count of Participants

Participants

From first dose until 4 weeks follow-up after the end of treatment

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Post-Hoc

Supplemental Oxygen Requirement in the ≤60% FiO2 Sub-population

Percentage of Subjects No Longer Requiring Supplemental Oxygen, for at Least 24 Hours by Day 14 in the ≤60% FiO2 FiO2 Sub-populations

Posted

Count of Participants

Participants

Day 14

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Post-Hoc

Supplemental Oxygen Requirement in the > 60% FiO2 Sub-population

Percentage of Subjects No Longer Requiring Supplemental Oxygen, for at Least 24 Hours by Day 14 in the > 60% FiO2 FiO2 Sub-populations

Posted

Count of Participants

Participants

Day 14

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Post-Hoc

Subjects With ≥ 2 Category Improvement on the WHO Ordinal Scale for Clinical Improvement by Day 14 Maintained to Day 42 in the FiO2 ≤ 60% Population

Post hoc analysis in the FiO2 ≤ 60% population. Compare ≥2 category improvement on the WHO Ordinal Scale for subjects taking opaganib and those on placebo, lower scores indicate improvement. Success was defined as subject who reached improvement of at least two points on the WHO Ordinal Scale by Day 14, maintained by the end of study visit day 42, and failure otherwise. WHO Ordinal Scale for Clinical Improvement is a scale from 0 (uninfected) to 8 (death) with higher scale poorer clinical status

Posted

Count of Participants

Participants

14 days maintained up to 42 days or classified as a failure

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Post-Hoc

Subjects With ≥ 2 Category Improvement on the WHO Ordinal Scale for Clinical Improvement by Day 14 up to Day 42 in the FiO2 > 60% Population

Post hoc analysis in the FiO2 > 60% population. Compare ≥2 category improvement on the WHO Clinical Ordinal Scale for subjects taking opaganib and those on placebo, lower scores indicate improvement. Success was defined as subject who reached improvement of at least two points on the WHO Ordinal Scale by Day 14, maintained by the end of study visit day 42 and failure otherwise.WHO Scale 0 to 8 with 8 death and higher number worse clinical state

Posted

Count of Participants

Participants

14 days maintained up to 42 days or classifed as failure

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Post-Hoc

Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement in the FiO2 ≤60% Population

Compare scores of subjects taking opaganib and those on placebo, lower scores indicate improvement.

WHO Ordinal Scale for Clinical Improvement with a scale ranging from 8 down to 0 with a higher score indicating a poorer clinical status

Posted

Count of Participants

Participants

14 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Post-Hoc

Number of Subjects With Improvement to a Score of 3 or Less on the WHO Ordinal Scale for Clinical Improvement in the FiO2 > 60% Population

Compare scores of subjects taking opaganib and those on placebo, lower scores indicate improvement.

World Health Organization Ordinal Scale for Clinical Improvement with a scale ranging from 8 down to 0 with a higher score indicating poorer clincal status

Posted

Count of Participants

Participants

14 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Post-Hoc

Number of Subjects Discharged From Hospital in the FiO2 ≤60% Population

Subjects discharged from the hospital in the FiO2 ≤60% population at 14 days

Posted

Count of Participants

Participants

14 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Post-Hoc

Number of Subjects Discharged From Hospital in the FiO2 > 60% Population

Number of subjects discharged from the hospital in the FiO2 > 60% population

Posted

Count of Participants

Participants

14 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Post-Hoc

Requiring Intubation and Mechanical Ventilation by Day 42 in the FiO2 ≤60% Population

To compare the proportion of patients in the FiO2 ≤60% sub-population requiring intubation and mechanical ventilation between subjects taking opaganib and those on placebo.

Subjects requiring intubation by Day 42 in the FiO2 ≤60% sub-population

Posted

Count of Participants

Participants

42 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Post-Hoc

Requiring Intubation and Mechanical Ventilation by Day 42 in the FiO2 > 60% Population

To compare the proportion of patients in the FiO2 > 60% sub-population requiring intubation and mechanical ventilation between subjects taking opaganib and those on placebo.

Subjects requiring intubation by Day 42 in the FiO2 ≤60% sub-population

Posted

Count of Participants

Participants

42 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Post-Hoc

Mortality Due to Any Cause in the FiO2 ≤60% Population

To compare mortality 28 and 42 days post-baseline between subjects taking opaganib and those taking placebo in the in the FiO2 ≤60% population

Mortality ("failure") was assessed by treatment Day 28 (including) and Day 42. Any early termination/ missing survival status at the end of study visit was also regarded as failure for the primary analysis of this endpoint.

For the FiO2 ≤60% Sub-population

Posted

Count of Participants

Participants

28 and 42 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Post-Hoc

Mortality Due to Any Cause in the FiO2 > 60% Population

To compare mortality 28 and 42 days post-baseline between subjects taking opaganib and those taking placebo in the in the FiO2 > 60% population

For the FiO2 > 60% Sub-population

Posted

Count of Participants

Participants

28 and 42 days

ID	Title	Description
OG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
OG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0004 events4 affected230 at risk EG0011 events1 affected233 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0015 events5 affected233 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG00010 events10 affected230 at risk EG00113 events13 affected233 at risk
Bacterial infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0012 events2 affected233 at risk
Candida infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Cardiac failure acute	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0012 events2 affected233 at risk
Cardiogenic shock	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Cellulitis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Cerebral thrombosis	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Confusional state	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Deep vein thrombosis	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0011 events1 affected233 at risk
Delirium	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Femoral artery embolism	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Haemodynamic instability	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0012 events2 affected233 at risk
Ischaemic stroke	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Mastoiditis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Mental status changes	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0011 events1 affected233 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Orchitis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Oxygen saturation decreased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Pneumonia	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG00011 events10 affected230 at risk EG0017 events6 affected233 at risk
Pneumonia bacterial	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0010 events0 affected233 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0007 events7 affected230 at risk EG0015 events5 affected233 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events2 affected233 at risk
Pulmonary sepsis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Pyrexia	General disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Renal impairment	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0014 events4 affected233 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG00018 events18 affected230 at risk EG00116 events16 affected233 at risk
Sepsis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0017 events7 affected233 at risk
Septic shock	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0005 events5 affected230 at risk EG0016 events6 affected233 at risk
Shock	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Troponin increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0012 events2 affected233 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected230 at risk EG0011 events1 affected233 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0011 events1 affected233 at risk
Abscess limb	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0004 events3 affected230 at risk EG0013 events3 affected233 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events1 affected233 at risk
Administration site phlebitis	General disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0010 events0 affected233 at risk
Agitation	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Alanine aminotransferase increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG00012 events12 affected230 at risk EG00114 events14 affected233 at risk
Amnesia	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0008 events4 affected230 at risk EG0013 events3 affected233 at risk
Anxiety	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0008 events8 affected230 at risk EG0013 events3 affected233 at risk
Anxiety disorder	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Arrhythmia	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0010 events0 affected233 at risk
Arthritis bacterial	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Aspartate aminotransferase increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0006 events6 affected230 at risk EG0014 events4 affected233 at risk
Asthenia	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0013 events3 affected233 at risk
Atrial fibrillation	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0008 events5 affected230 at risk EG0013 events3 affected233 at risk
Axillary vein thrombosis	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0004 events4 affected230 at risk EG0014 events4 affected233 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Blood creatinine increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0013 events3 affected233 at risk
Blood glucose increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Blood lactic acid increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Blood potassium decreased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Blood potassium increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Blood pressure diastolic decreased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Blood pressure increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0015 events4 affected233 at risk
Blood sodium increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Blue toe syndrome	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Body temperature increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Bradycardia	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0012 events2 affected233 at risk
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Bundle branch block left	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
C-reactive protein increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0011 events1 affected233 at risk
Calculus urinary	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Cardiac failure	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Cerebral atrophy	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Chapped lips	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Chest discomfort	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Chest pain	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0012 events2 affected233 at risk
Clostridium difficile infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Colitis	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Constipation	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG00023 events22 affected230 at risk EG00124 events24 affected233 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected230 at risk EG0015 events5 affected233 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0011 events1 affected233 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected230 at risk EG0012 events2 affected233 at risk
Deep vein thrombosis	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0013 events3 affected233 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0012 events2 affected233 at risk
Depression	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected230 at risk EG0012 events2 affected233 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0013 events3 affected233 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0006 events6 affected230 at risk EG0016 events6 affected233 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Dizziness	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0005 events5 affected230 at risk EG0013 events2 affected233 at risk
Dry mouth	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Dysaesthesia	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Dysgeusia	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0008 events7 affected230 at risk EG0011 events1 affected233 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0014 events3 affected233 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Dystonia	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Dysuria	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected230 at risk EG0014 events4 affected233 at risk
Enterococcal infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Enterococcus test positive	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events2 affected233 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Essential hypertension	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events2 affected233 at risk
Eye irritation	Eye disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Feeling cold	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Fibrin D dimer increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0013 events3 affected233 at risk
Flatulence	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events2 affected233 at risk
Flushing	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Fungal skin infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Gastritis	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Haematoma	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Haematuria	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Haemochromatosis	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Haemodynamic instability	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Haemoglobin decreased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Hallucination, visual	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0012 events2 affected233 at risk
Headache	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0008 events8 affected230 at risk EG0014 events4 affected233 at risk
Hepatic enzyme increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0012 events2 affected233 at risk
Hepatitis	Hepatobiliary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Hepatitis B core antibody positive	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Herpes virus infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0010 events0 affected233 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected230 at risk EG0016 events6 affected233 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0010 events0 affected233 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0009 events9 affected230 at risk EG00111 events8 affected233 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events2 affected233 at risk
Hypertension	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0005 events4 affected230 at risk EG0016 events6 affected233 at risk
Hypertensive crisis	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Hypertensive urgency	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Hypoaesthesia	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0005 events4 affected230 at risk EG0013 events2 affected233 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events2 affected233 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0011 events1 affected233 at risk
Hypoproteinaemia	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Hypotension	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0008 events7 affected230 at risk EG0016 events6 affected233 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0013 events3 affected233 at risk
Infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Inflammatory marker increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Injection site haematoma	General disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events2 affected233 at risk
Insomnia	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG00018 events17 affected230 at risk EG0019 events9 affected233 at risk
Interleukin level increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Klebsiella infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Klebsiella test positive	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events2 affected233 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0012 events2 affected233 at risk
Lip injury	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Liver function test abnormal	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Mastoiditis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Mechanical ventilation	Surgical and medical procedures	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Mental disorder due to a general medical condition	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Mental impairment	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0010 events0 affected233 at risk
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events1 affected233 at risk
Migraine	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0012 events2 affected233 at risk
Myopia	Eye disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Nausea	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG00013 events12 affected230 at risk EG0013 events3 affected233 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Non-cardiac chest pain	General disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0012 events2 affected233 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Ocular hyperaemia	Eye disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Oedema peripheral	General disorders	MedDRA version 23.1	Systematic Assessment	EG0006 events6 affected230 at risk EG0015 events5 affected233 at risk
Oral candidiasis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0018 events8 affected233 at risk
Oral herpes	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Otitis media acute	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Oxygen saturation decreased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0015 events5 affected233 at risk
Pain	General disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0013 events3 affected233 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Palpitations	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Panic attack	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Papule	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Paraesthesia	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Paranasal sinus inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Parkinsonism	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Persistent depressive disorder	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Phlebitis	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected230 at risk EG0010 events0 affected233 at risk
Photophobia	Eye disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Platelet count increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Pneumonia	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0006 events5 affected230 at risk EG0011 events1 affected233 at risk
Pneumonia bacterial	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0011 events1 affected233 at risk
Pneumonia necrotising	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Pollakiuria	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Post intensive care syndrome	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events2 affected233 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0006 events6 affected230 at risk EG0011 events1 affected233 at risk
Pupils unequal	Eye disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Purulent discharge	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Pyrexia	General disorders	MedDRA version 23.1	Systematic Assessment	EG0008 events7 affected230 at risk EG0013 events3 affected233 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Renal colic	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Renal failure	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0011 events1 affected233 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0006 events6 affected230 at risk EG0017 events6 affected233 at risk
Retinal haemorrhage	Eye disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Scrotal dermatitis	Reproductive system and breast disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Sepsis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Septic shock	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Serratia infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Serum ferritin increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Shock haemorrhagic	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Sinus bradycardia	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0012 events2 affected233 at risk
Sinus tachycardia	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Sleep disorder	Psychiatric disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Somnolence	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0014 events4 affected233 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Sputum purulent	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events2 affected233 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0003 events3 affected230 at risk EG0010 events0 affected233 at risk
Steroid diabetes	Metabolism and nutrition disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0010 events0 affected233 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0011 events1 affected233 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Syncope	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Tachycardia	Cardiac disorders	MedDRA version 23.1	Systematic Assessment	EG0004 events4 affected230 at risk EG00115 events11 affected233 at risk
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 23.1	Systematic Assessment	EG0005 events4 affected230 at risk EG0017 events5 affected233 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 23.1	Systematic Assessment	EG0004 events4 affected230 at risk EG0015 events4 affected233 at risk
Thrombophlebitis	Vascular disorders	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0010 events0 affected233 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Tongue discolouration	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Tongue fungal infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Tracheitis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Tracheobronchitis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Transaminases increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0014 events4 affected233 at risk
Tremor	Nervous system disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Urinary retention	Renal and urinary disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0013 events2 affected233 at risk
Urinary tract infection	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0002 events2 affected230 at risk EG0016 events6 affected233 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Vertigo	Ear and labyrinth disorders	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
Vision blurred	Eye disorders	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0011 events1 affected233 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 23.1	Systematic Assessment	EG0004 events4 affected230 at risk EG0012 events2 affected233 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA version 23.1	Systematic Assessment	EG0001 events1 affected230 at risk EG0010 events0 affected233 at risk
White blood cell count increased	Investigations	MedDRA version 23.1	Systematic Assessment	EG0000 events0 affected230 at risk EG0012 events2 affected233 at risk

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description
BG000	Opaganib	Opaganib administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. When required this may be made into a suspension form and may be administered by nasogastric tube.
BG001	Placebo	Matching placebo administered orally in 2 x 250 mg capsules (500 mg) every 12 hours every day for 14 days (Day 1 to Day 14) in addition to standard of care. Where required this may be made into a suspension form and may be administered by nasogastric tube.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Opaganib	Standard of care + opaganib, 2 x 250 mg oral capsules (500 mg), every 12 hours, for 14 days (Day 1 to Day 14).	44	230	52	230	155	230
EG001	Placebo	Standard of care + matching placebo, 2 x 250 mg oral capsules (500 mg), every 12 hours, for 14 days (Day 1 to Day 14).	47	233	52	233	147	233