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Clinical Trial Results:
Expanded Access Treatment Protocol: Remdesivir (RDV; GS-5734) for the Treatment of SARS-CoV2 (CoV) Infection

Summary
EudraCT number	2020-001453-49
Trial protocol	ES
Global end of trial date	23 Sep 2020

Results information
Results version number	v1(current)
This version publication date	02 Oct 2021
First version publication date	02 Oct 2021
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

Top of page

Sponsor protocol code

GS-US-540-5821

ISRCTN number

-

US NCT number

NCT04323761

WHO universal trial number (UTN)

-

Sponsor organisation name

Gilead Sciences

Sponsor organisation address

333 Lakeside Drive, Foster City, CA, United States, 94404

Public contact

Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com

Scientific contact

Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

23 Sep 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

23 Sep 2020

Global end of trial reached?

Yes

Global end of trial date

23 Sep 2020

Was the trial ended prematurely?

No

Main objective of the trial

The primary objective of this study was to provide expanded access of remdesivir for the treatment of serious acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Protection of trial subjects

The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

27 Mar 2020

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Spain: 36

Country: Number of subjects enrolled

United States: 1719

Country: Number of subjects enrolled

Italy: 109

Country: Number of subjects enrolled

Poland: 80

Country: Number of subjects enrolled

Switzerland: 34

Country: Number of subjects enrolled

Netherlands: 29

Country: Number of subjects enrolled

France: 25

Country: Number of subjects enrolled

Denmark: 23

Country: Number of subjects enrolled

United Kingdom: 21

Country: Number of subjects enrolled

Portugal: 19

Country: Number of subjects enrolled

Austria: 17

Country: Number of subjects enrolled

Australia: 16

Country: Number of subjects enrolled

Israel: 14

Country: Number of subjects enrolled

Germany: 9

Country: Number of subjects enrolled

Romania: 9

Country: Number of subjects enrolled

Belgium: 8

Country: Number of subjects enrolled

Hungary: 5

Country: Number of subjects enrolled

Slovenia: 5

Country: Number of subjects enrolled

Canada: 4

Country: Number of subjects enrolled

Czechia: 3

Country: Number of subjects enrolled

Slovakia: 3

Country: Number of subjects enrolled

Estonia: 1

Country: Number of subjects enrolled

Greece: 1

Country: Number of subjects enrolled

Ireland: 1

Worldwide total number of subjects

2191

EEA total number of subjects

383

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

1332

From 65 to 84 years

803

85 years and over

56

Subject disposition

Top of page

Recruitment details

Participants were enrolled at study sites in Australia, Canada, Europe, Israel, and United States. The first participant was screened on 27 March 2020. The last study visit occurred on 23 September 2020.

Screening details

2191 participants were screened and enrolled. There were 3 participants whose age was not known. These 3 participants are added to the “Adults (18-64)” category in the Trial Information section because there is no separate age category for “missing”.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Remdesivir 10 Days

Arm description

Participants who required mechanical ventilation at baseline received intravenous (IV) infusion of remdesivir 200 mg on Day 1 followed by IV infusion of remdesivir 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Arm type

Experimental

Investigational medicinal product name

Remdesivir

Investigational medicinal product code

Other name

GS-5734™, Veklury®

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

200 mg administered on Day 1 followed by 100 mg up to Day 10.

Remdesivir 5 Days

Arm description

Participants who were not on mechanical ventilation at baseline received IV infusion of remdesivir 200 mg on Day 1 followed by IV infusion of remdesivir 100 mg on Days 2, 3, 4, and 5. Participants originally not requiring mechanical ventilation at baseline who subsequently required mechanical ventilation prior to the Day 5 dose continued to receive remdesivir for up to 10 days.

Arm type

Experimental

Investigational medicinal product name

Remdesivir

Investigational medicinal product code

Other name

GS-5734™, Veklury®

Pharmaceutical forms

Concentrate for solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

200 mg administered on Day 1 followed by 100 mg up to Day 10.

Number of subjects in period 1 ^[1]	Remdesivir 10 Days	Remdesivir 5 Days
Started	1786	293
Completed	1786	293

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: 109 participants who were enrolled but not treated and 3 participants who had missing mechanical ventilation status at baseline were not included in the Safety Analysis Set for Period 1 table reported above.

Baseline characteristics

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Reporting group title

Remdesivir 10 Days

Reporting group description

Participants who required mechanical ventilation at baseline received intravenous (IV) infusion of remdesivir 200 mg on Day 1 followed by IV infusion of remdesivir 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Reporting group title

Remdesivir 5 Days

Reporting group description

Participants who were not on mechanical ventilation at baseline received IV infusion of remdesivir 200 mg on Day 1 followed by IV infusion of remdesivir 100 mg on Days 2, 3, 4, and 5. Participants originally not requiring mechanical ventilation at baseline who subsequently required mechanical ventilation prior to the Day 5 dose continued to receive remdesivir for up to 10 days.

Reporting group values	Remdesivir 10 Days	Remdesivir 5 Days	Total
Number of subjects	1786	293	2079
Age categorical
Units: Subjects
< 50	379	66	445
≥ 50 - < 65	726	97	823
≥ 65 - < 75	485	70	555
≥ 75	195	60	255
Missing	1	0	1
Gender categorical
Units: Subjects
Female	614	107	721
Male	1172	186	1358
Race
Not Permitted = local regulators did not allow collection of race or ethnicity information
Units: Subjects
American Indian or Alaska Native	13	0	13
Asian	143	20	163
Black	270	27	297
Native Hawaiian or Pacific Islander	9	0	9
White	920	217	1137
Not Permitted	123	9	132
Other	279	18	297
Missing	29	2	31
Ethnicity
Not Permitted = local regulators did not allow collection of race or ethnicity information
Units: Subjects
Hispanic or Latino	611	38	649
Not Hispanic or Latino	1076	241	1317
Not Permitted	60	13	73
Missing	39	1	40

End points

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Reporting group title

Remdesivir 10 Days

Reporting group description

Participants who required mechanical ventilation at baseline received intravenous (IV) infusion of remdesivir 200 mg on Day 1 followed by IV infusion of remdesivir 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Reporting group title

Remdesivir 5 Days

Reporting group description

Participants who were not on mechanical ventilation at baseline received IV infusion of remdesivir 200 mg on Day 1 followed by IV infusion of remdesivir 100 mg on Days 2, 3, 4, and 5. Participants originally not requiring mechanical ventilation at baseline who subsequently required mechanical ventilation prior to the Day 5 dose continued to receive remdesivir for up to 10 days.

Primary: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs)

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End point title

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) ^[1]

End point description

An AE was any untoward medical occurrence in a participant administered study drug, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A treatment-emergent AE was defined as any AE that began on or after the date of first dose of study drug up to the date of last dose of study drug plus 30 days. The Safety Analysis Set included all participants who received at least 1 dose of study drug.

End point type

Primary

End point timeframe

First dose date up to last dose (Day 10) plus 30 days

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Remdesivir 10 Days	Remdesivir 5 Days
Number of subjects analysed	1786	293
Units: percentage of participants
number (not applicable)	67.1	36.2

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Adverse Events: First dose date up to last dose (Day 10) plus 30 days; All-Cause Mortality: Enrollment up to the end of study (maximum: up to 49 days)

Adverse event reporting additional description

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

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

22

Reporting group title

Remdesivir 10 Days

Reporting group description

Participants who required mechanical ventilation at Baseline received IV infusion of remdesivir 200 mg on Day 1 followed by IV infusion of remdesivir 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

Reporting group title

Remdesivir 5 Days

Reporting group description

Participants who were not on mechanical ventilation at Baseline received IV infusion of remdesivir 200 mg on Day 1 followed by IV infusion of remdesivir 100 mg on Days 2, 3, 4, and 5. Participants originally not requiring mechanical ventilation at baseline who subsequently required mechanical ventilation prior to the Day 5 dose continued to receive remdesivir for up to 10 days.

Serious adverse events	Remdesivir 10 Days	Remdesivir 5 Days
Total subjects affected by serious adverse events
subjects affected / exposed	865 / 1786 (48.43%)	58 / 293 (19.80%)
number of deaths (all causes)	761	48
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Plasma cell myeloma
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Vascular disorders
Hypotension
subjects affected / exposed	34 / 1786 (1.90%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 34	0 / 1
deaths causally related to treatment / all	0 / 11	0 / 0
Shock
subjects affected / exposed	17 / 1786 (0.95%)	3 / 293 (1.02%)
occurrences causally related to treatment / all	0 / 17	0 / 3
deaths causally related to treatment / all	0 / 10	0 / 1
Haemodynamic instability
subjects affected / exposed	9 / 1786 (0.50%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 9	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Shock haemorrhagic
subjects affected / exposed	8 / 1786 (0.45%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 8	0 / 0
deaths causally related to treatment / all	1 / 6	0 / 0
Hypertension
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	2 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Peripheral ischaemia
subjects affected / exposed	1 / 1786 (0.06%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bloody discharge
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Circulatory collapse
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cyanosis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Haemorrhage
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypertensive urgency
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotensive crisis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Peripheral artery thrombosis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
Extubation
subjects affected / exposed	4 / 1786 (0.22%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 0
Hospice care
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
General disorders and administration site conditions
Multiple organ dysfunction syndrome
subjects affected / exposed	79 / 1786 (4.42%)	10 / 293 (3.41%)
occurrences causally related to treatment / all	1 / 79	0 / 10
deaths causally related to treatment / all	1 / 72	0 / 10
Cardiac death
subjects affected / exposed	6 / 1786 (0.34%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 5	0 / 0
Death
subjects affected / exposed	4 / 1786 (0.22%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 4	0 / 0
Pyrexia
subjects affected / exposed	2 / 1786 (0.11%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Brain death
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Multi-organ disorder
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Complication associated with device
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Condition aggravated
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Drug interaction
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperthermia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Immune system disorders
Cytokine storm
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Respiratory, thoracic and mediastinal disorders
Respiratory failure
subjects affected / exposed	141 / 1786 (7.89%)	19 / 293 (6.48%)
occurrences causally related to treatment / all	1 / 141	0 / 19
deaths causally related to treatment / all	1 / 112	0 / 15
Acute respiratory failure
subjects affected / exposed	77 / 1786 (4.31%)	3 / 293 (1.02%)
occurrences causally related to treatment / all	0 / 77	0 / 3
deaths causally related to treatment / all	0 / 71	0 / 1
Pneumothorax
subjects affected / exposed	54 / 1786 (3.02%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 54	0 / 1
deaths causally related to treatment / all	0 / 17	0 / 0
Acute respiratory distress syndrome
subjects affected / exposed	40 / 1786 (2.24%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 40	0 / 1
deaths causally related to treatment / all	0 / 35	0 / 1
Hypoxia
subjects affected / exposed	30 / 1786 (1.68%)	2 / 293 (0.68%)
occurrences causally related to treatment / all	0 / 30	0 / 2
deaths causally related to treatment / all	0 / 20	0 / 0
Pulmonary embolism
subjects affected / exposed	17 / 1786 (0.95%)	2 / 293 (0.68%)
occurrences causally related to treatment / all	0 / 17	0 / 2
deaths causally related to treatment / all	0 / 13	0 / 1
Respiratory distress
subjects affected / exposed	18 / 1786 (1.01%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 19	0 / 1
deaths causally related to treatment / all	0 / 10	0 / 0
Respiratory disorder
subjects affected / exposed	11 / 1786 (0.62%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 11	0 / 1
deaths causally related to treatment / all	0 / 7	0 / 0
Pneumomediastinum
subjects affected / exposed	6 / 1786 (0.34%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Respiratory acidosis
subjects affected / exposed	5 / 1786 (0.28%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 3	0 / 0
Pleural effusion
subjects affected / exposed	4 / 1786 (0.22%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory arrest
subjects affected / exposed	3 / 1786 (0.17%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 3	0 / 1
Dyspnoea
subjects affected / exposed	2 / 1786 (0.11%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Haemothorax
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Lung consolidation
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumothorax spontaneous
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary haemorrhage
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 0
Chronic obstructive pulmonary disease
subjects affected / exposed	1 / 1786 (0.06%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Dependence on respirator
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Epistaxis
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hypercapnia
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Pneumonitis
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Bronchial secretion retention
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cystic lung disease
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea exertional
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Interstitial lung disease
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Lung opacity
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mediastinal haemorrhage
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumonia aspiration
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary fibrosis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pulmonary oedema
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Respiratory gas exchange disorder
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Stridor
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tachypnoea
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Psychiatric disorders
Delirium
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Intensive care unit delirium
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Product issues
Device connection issue
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device dislocation
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Device leakage
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombosis in device
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	19 / 1786 (1.06%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	8 / 19	0 / 1
deaths causally related to treatment / all	0 / 6	0 / 0
Blood creatinine increased
subjects affected / exposed	16 / 1786 (0.90%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	2 / 16	0 / 0
deaths causally related to treatment / all	0 / 5	0 / 0
Aspartate aminotransferase increased
subjects affected / exposed	13 / 1786 (0.73%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	6 / 13	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Liver function test increased
subjects affected / exposed	13 / 1786 (0.73%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	4 / 13	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Transaminases increased
subjects affected / exposed	8 / 1786 (0.45%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	8 / 8	0 / 1
deaths causally related to treatment / all	1 / 1	0 / 0
Creatinine renal clearance abnormal
subjects affected / exposed	8 / 1786 (0.45%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 8	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Creatinine renal clearance decreased
subjects affected / exposed	7 / 1786 (0.39%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Glomerular filtration rate abnormal
subjects affected / exposed	6 / 1786 (0.34%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	2 / 6	0 / 1
deaths causally related to treatment / all	1 / 1	0 / 1
Blood bilirubin increased
subjects affected / exposed	4 / 1786 (0.22%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	3 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Glomerular filtration rate decreased
subjects affected / exposed	3 / 1786 (0.17%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 3	1 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Haemoglobin decreased
subjects affected / exposed	4 / 1786 (0.22%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oxygen saturation decreased
subjects affected / exposed	3 / 1786 (0.17%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic enzyme increased
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Staphylococcus test positive
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aspergillus test positive
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatine phosphokinase increased
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood creatinine abnormal
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Klebsiella test positive
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Alanine aminotransferase abnormal
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Aspartate aminotransferase abnormal
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood alkaline phosphatase increased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood bilirubin abnormal
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood potassium abnormal
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Blood pressure abnormal
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Blood sodium decreased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Blood urea increased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
C-reactive protein increased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Carbon dioxide abnormal
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Chest X-ray abnormal
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Computerised tomogram abdomen abnormal
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Creatinine renal clearance increased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Electrocardiogram QRS complex prolonged
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Electrocardiogram T wave inversion
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Fibrin D dimer increased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fungal test positive
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gram stain positive
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Inflammatory marker increased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Low density lipoprotein increased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mean arterial pressure decreased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oxygen saturation abnormal
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Serum ferritin increased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Troponin increased
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Urine output decreased
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Injury, poisoning and procedural complications
Brain herniation
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 0
Barotrauma
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Endotracheal intubation complication
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal procedural complication
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Infusion related reaction
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mechanical ventilation complication
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Post procedural haemorrhage
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Post procedural oedema
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Product dose omission issue
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheal injury
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Tracheostomy malfunction
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiac disorders
Cardiac arrest
subjects affected / exposed	163 / 1786 (9.13%)	8 / 293 (2.73%)
occurrences causally related to treatment / all	3 / 165	0 / 8
deaths causally related to treatment / all	3 / 137	0 / 7
Cardio-respiratory arrest
subjects affected / exposed	72 / 1786 (4.03%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 73	0 / 0
deaths causally related to treatment / all	1 / 67	0 / 0
Pulseless electrical activity
subjects affected / exposed	16 / 1786 (0.90%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 16	0 / 0
deaths causally related to treatment / all	0 / 9	0 / 0
Bradycardia
subjects affected / exposed	12 / 1786 (0.67%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 12	0 / 0
deaths causally related to treatment / all	0 / 8	0 / 0
Atrial fibrillation
subjects affected / exposed	6 / 1786 (0.34%)	2 / 293 (0.68%)
occurrences causally related to treatment / all	0 / 6	0 / 2
deaths causally related to treatment / all	0 / 2	0 / 0
Cardiac failure
subjects affected / exposed	6 / 1786 (0.34%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 4	0 / 0
Cardiogenic shock
subjects affected / exposed	6 / 1786 (0.34%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 6	0 / 1
deaths causally related to treatment / all	0 / 4	0 / 0
Supraventricular tachycardia
subjects affected / exposed	6 / 1786 (0.34%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 7	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Arrhythmia
subjects affected / exposed	6 / 1786 (0.34%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 4	0 / 0
Tachycardia
subjects affected / exposed	4 / 1786 (0.22%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	2 / 4	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 0
Ventricular tachycardia
subjects affected / exposed	5 / 1786 (0.28%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Myocarditis
subjects affected / exposed	2 / 1786 (0.11%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Acute myocardial infarction
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac failure acute
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Myocardial infarction
subjects affected / exposed	1 / 1786 (0.06%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Sinus arrest
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Sinus tachycardia
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Ventricular arrhythmia
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Atrial flutter
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorder
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cardiac failure congestive
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiopulmonary failure
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Cardiovascular insufficiency
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cor pulmonale
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Extrasystoles
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Right ventricular failure
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Sinus bradycardia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ventricular fibrillation
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	7 / 1786 (0.39%)	3 / 293 (1.02%)
occurrences causally related to treatment / all	0 / 7	0 / 3
deaths causally related to treatment / all	0 / 3	0 / 1
Encephalopathy
subjects affected / exposed	7 / 1786 (0.39%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Haemorrhage intracranial
subjects affected / exposed	7 / 1786 (0.39%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 7	0 / 0
deaths causally related to treatment / all	0 / 4	0 / 0
Cerebral haemorrhage
subjects affected / exposed	6 / 1786 (0.34%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 6	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 0
Haemorrhagic stroke
subjects affected / exposed	5 / 1786 (0.28%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 3	0 / 0
Metabolic encephalopathy
subjects affected / exposed	4 / 1786 (0.22%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral infarction
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Ischaemic stroke
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Seizure
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Toxic encephalopathy
subjects affected / exposed	2 / 1786 (0.11%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Intensive care unit acquired weakness
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Basal ganglia haematoma
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Brain injury
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Brain oedema
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Cerebellar infarction
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cerebral ischaemia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coma
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Generalised tonic-clonic seizure
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypotonia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hypoxic-ischaemic encephalopathy
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Lethargy
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Mental impairment
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Moyamoya disease
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tremor
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Unresponsive to stimuli
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	8 / 1786 (0.45%)	2 / 293 (0.68%)
occurrences causally related to treatment / all	0 / 8	0 / 2
deaths causally related to treatment / all	0 / 1	0 / 1
Disseminated intravascular coagulation
subjects affected / exposed	5 / 1786 (0.28%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Blood loss anaemia
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Leukocytosis
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Coagulopathy
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Heparin-induced thrombocytopenia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Dysphagia
subjects affected / exposed	14 / 1786 (0.78%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 14	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	12 / 1786 (0.67%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 12	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Retroperitoneal haemorrhage
subjects affected / exposed	4 / 1786 (0.22%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	2 / 4	0 / 0
deaths causally related to treatment / all	2 / 3	0 / 0
Mouth haemorrhage
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Haematochezia
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Ileus
subjects affected / exposed	1 / 1786 (0.06%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Intra-abdominal haemorrhage
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	1 / 2	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Oedematous pancreatitis
subjects affected / exposed	1 / 1786 (0.06%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Rectal haemorrhage
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Colitis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Colitis ischaemic
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Diverticular perforation
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Duodenal ulcer perforation
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastric ulcer
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorder
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Gastrointestinal necrosis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Intestinal ischaemia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Large intestine perforation
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Obstruction gastric
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pancreatitis
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Retroperitoneal haematoma
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Hepatic failure
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Liver injury
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Acute hepatic failure
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	1 / 1	0 / 0
Drug-induced liver injury
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hepatitis toxic
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Liver disorder
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Non-alcoholic steatohepatitis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Angioedema
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Decubitus ulcer
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rash macular
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Rash maculo-papular
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	137 / 1786 (7.67%)	3 / 293 (1.02%)
occurrences causally related to treatment / all	11 / 138	0 / 3
deaths causally related to treatment / all	2 / 25	0 / 1
Renal failure
subjects affected / exposed	28 / 1786 (1.57%)	5 / 293 (1.71%)
occurrences causally related to treatment / all	2 / 28	1 / 5
deaths causally related to treatment / all	1 / 11	0 / 1
Renal impairment
subjects affected / exposed	8 / 1786 (0.45%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	1 / 8	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Haematuria
subjects affected / exposed	5 / 1786 (0.28%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal tubular necrosis
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Azotaemia
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Renal injury
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Anuria
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Oliguria
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Proteinuria
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract obstruction
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Septic shock
subjects affected / exposed	79 / 1786 (4.42%)	4 / 293 (1.37%)
occurrences causally related to treatment / all	1 / 81	0 / 4
deaths causally related to treatment / all	1 / 53	0 / 3
Pneumonia
subjects affected / exposed	30 / 1786 (1.68%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 30	0 / 1
deaths causally related to treatment / all	0 / 22	0 / 1
Covid-19
subjects affected / exposed	29 / 1786 (1.62%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 29	0 / 0
deaths causally related to treatment / all	0 / 29	0 / 0
Sepsis
subjects affected / exposed	21 / 1786 (1.18%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 21	0 / 1
deaths causally related to treatment / all	0 / 10	0 / 1
Covid-19 pneumonia
subjects affected / exposed	18 / 1786 (1.01%)	3 / 293 (1.02%)
occurrences causally related to treatment / all	0 / 18	0 / 3
deaths causally related to treatment / all	0 / 16	0 / 3
Systemic candida
subjects affected / exposed	5 / 1786 (0.28%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 5	0 / 1
deaths causally related to treatment / all	0 / 3	0 / 0
Staphylococcal bacteraemia
subjects affected / exposed	4 / 1786 (0.22%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 4	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Pneumonia bacterial
subjects affected / exposed	4 / 1786 (0.22%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Pneumonia staphylococcal
subjects affected / exposed	3 / 1786 (0.17%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 2	0 / 0
Bacteraemia
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Bacterial infection
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Pneumonia acinetobacter
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Staphylococcal sepsis
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Acinetobacter infection
subjects affected / exposed	1 / 1786 (0.06%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 1	0 / 1
Bacterial sepsis
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Klebsiella bacteraemia
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumonia viral
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Acinetobacter sepsis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Bacterial abdominal infection
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
Bacterial tracheitis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Candida infection
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Empyema
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Enterococcal sepsis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia bacteraemia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Escherichia infection
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Escherichia sepsis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Klebsiella sepsis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Nosocomial infection
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumocystis jirovecii pneumonia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pneumonia escherichia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pseudomembranous colitis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Pseudomonal bacteraemia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Severe acute respiratory syndrome
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Staphylococcal infection
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0
Streptococcal bacteraemia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Viral infection
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Metabolic acidosis
subjects affected / exposed	6 / 1786 (0.34%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 6	0 / 0
deaths causally related to treatment / all	1 / 2	0 / 0
Hyperkalaemia
subjects affected / exposed	5 / 1786 (0.28%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Acidosis
subjects affected / exposed	4 / 1786 (0.22%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0
deaths causally related to treatment / all	0 / 2	0 / 0
Hypernatraemia
subjects affected / exposed	3 / 1786 (0.17%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Fluid overload
subjects affected / exposed	1 / 1786 (0.06%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	1 / 1786 (0.06%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolic alkalosis
subjects affected / exposed	2 / 1786 (0.11%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Decreased appetite
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Hypocalcaemia
subjects affected / exposed	0 / 1786 (0.00%)	1 / 293 (0.34%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypomagnesaemia
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Malnutrition
subjects affected / exposed	1 / 1786 (0.06%)	0 / 293 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Remdesivir 10 Days	Remdesivir 5 Days
Total subjects affected by non serious adverse events
subjects affected / exposed	151 / 1786 (8.45%)	19 / 293 (6.48%)
Investigations
Alanine aminotransferase increased
subjects affected / exposed	56 / 1786 (3.14%)	17 / 293 (5.80%)
occurrences all number	56	17
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	99 / 1786 (5.54%)	2 / 293 (0.68%)
occurrences all number	100	2

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Were there any global substantial amendments to the protocol? Yes

06 Apr 2020

- Per regulatory agency requests, study eligibility criteria have been expanded to include pregnant participants and adolescents, to exclude participants who are eligible for participation on a randomized clinical trial studying remdesivir for treatment of SARS-CoV2 at the medical facility where the participant is admitted, and to exclude participants with a known hypersensitivity to the study drug, the metabolites, or formulation excipient. Additional criteria for permanent discontinuation of study drug were included, should the participant develop alanine transaminase (ALT) levels ≥ 3 * upper limit of normal (ULN) and bilirubin ≥ 2 * ULN or experience acute anaphylactic reaction to remdesivir. - New protocol study procedures were added in for follow-up assessments (on-site or telephone) on Day 15 and Day 28. - Increased number of participants to up to approximately 15,000. - The study protocol has also been revised to include additional details and clarity regarding the following topics: Study drug formulation, storage and handling, and accountability; Prohibited concomitant medications; Study procedures; Serious adverse event reporting; Telephone consent; Study files and retention of records; Financial disclosures; and Case report forms.

15 May 2020

- Updated eligibility criteria: a) Removed invasive mechanical ventilation as inclusion criteria to expand the target population. The revised inclusion criteria requires participants to have oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen at baseline. b) Revised liver function test (LFT) inclusion criteria, added contraception inclusion criteria, and added lactating women and nursing inclusion criteria. c) Added venous arterial (V-A) extracorporeal membrane oxygenation (ECMO) exclusion criteria. - The remdesivir treatment course duration is modified to align with the United States Food and Drug Administration (US FDA) emergency use authorization fact sheet and Committee for Medicinal Products for Human Use (CHMP) Article 83 compassionate use recommendations for participants who are not on invasive mechanical ventilation. These participants will receive a 5 day treatment course. Any participant who is not on invasive mechanical ventilation at baseline, but requires invasive mechanical ventilation prior to the Day 5 dose should continue to receive remdesivir on Days 6, 7, 8, 9, and 10. - Study procedures updates: a) Baseline procedures must be done within 2 days prior to enrollment. b) Pregnancy testing is noted as a baseline assessment. c) Laboratory testing procedures are modified to specify those which should be done daily to ensure participant safety. All other laboratory testing is to be done as per local standard of care. d) Follow-up assessment visit windows were expanded. e) Added guidance regarding study drug restart after an interruption. f) Study Procedures Table was added to present the procedures to be done for participants who do not require mechanical ventilation at baseline. - Serious adverse reporting will now be done primarily through electronic submission in the electronic case report form (eCRF) system.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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