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Clinical Trial Results:
A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients with COVID-19

Summary
EudraCT number	2020-002537-15
Trial protocol	RO
Global end of trial date	22 Oct 2021

Results information
Results version number	v1(current)
This version publication date	06 Nov 2022
First version publication date	06 Nov 2022
Other versions

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

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Trial information

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Sponsor protocol code

R10933-10987-COV-2066

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Regeneron Pharmaceuticals, Inc

Sponsor organisation address

777 Old Saw Mill River Rd., Tarrytown, United States, 10591

Public contact

Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 8447346643, clinicaltrials@regeneron.com

Scientific contact

Clinical Trial Management, Regeneron Pharmaceuticals, Inc, 001 8447346643, clinicaltrials@regeneron.com

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

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

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

Analysis stage

Final

Date of interim/final analysis

22 Oct 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

22 Oct 2021

Was the trial ended prematurely?

Main objective of the trial

The primary objectives are: Pooled Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) • To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 • To evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation Phase 1/2 (Cohort 1) • To exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation • To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo

Protection of trial subjects

It is the responsibility of both the sponsor and the investigator(s) to ensure that this clinical study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with the ICH guidelines for GCP and applicable regulatory requirements

Background therapy

Evidence for comparator

Actual start date of recruitment

10 Jun 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Brazil: 65

Country: Number of subjects enrolled

Chile: 6

Country: Number of subjects enrolled

Mexico: 102

Country: Number of subjects enrolled

Moldova, Republic of: 87

Country: Number of subjects enrolled

Romania: 16

Country: Number of subjects enrolled

United States: 1927

Worldwide total number of subjects

2203

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

1233

From 65 to 84 years

799

85 years and over

171

Subject disposition

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Recruitment details

Screening details

A total of 2324 participants were screened and 2203 participants randomized and treated, 49 participants were randomized but not treated, and 72 discontinued at the screening phase. Reasons for discontinuation at screening phase: 54 - Screen Failure, 10 - Subject Decision, 1- Sponsor Request, 7- Other.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Data analyst, Assessor

Are arms mutually exclusive

Yes

Phase 1: Cohort 1 (Placebo)

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo matching to R10933+R10987

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of placebo matching to R10933+R10987 intravenously on Day 1

Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)

Arm description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 milligrams (mg) intravenously on Day 1 in Phase 1 (Cohort 1).

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 2400 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 2400 mg IV R10933+R10987 intravenously on Day 1

Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)

Arm description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 1 (Cohort 1).

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 8000 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 8000 mg IV R10933+R10987 intravenously on Day 1

Phase 2: Cohort 1 (Placebo)

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo matching to R10933+R10987

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of placebo matching to R10933+R10987 intravenously on Day 1

Phase 2: Cohort 1 (R10933+R10987 2400 mg

Arm description

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 2400 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 2400 mg IV R10933+R10987 intravenously on Day 1

Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)

Arm description

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 8000 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 8000 mg IV R10933+R10987 intravenously on Day 1

Phase 3: Cohort 1 (Placebo)

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo matching to R10933+R10987

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of placebo matching to R10933+R10987 intravenously on Day 1

Phase 3: Cohort 1 (R10933+R10987 2400 mg)

Arm description

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 2400 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 2400 mg IV R10933+R10987 intravenously on Day 1

Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)

Arm description

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 8000 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 8000 mg IV R10933+R10987 intravenously on Day 1

Phase 2: Cohort 1A (Placebo)

Arm description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).

Arm type

Placebo

Investigational medicinal product name

Placebo matching to R10933+R10987

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of placebo matching to R10933+R10987 intravenously on Day 1

Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)

Arm description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 2400 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 2400 mg IV R10933+R10987 intravenously on Day 1

Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)

Arm description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 8000 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 8000 mg IV R10933+R10987 intravenously on Day 1

Phase 2: Cohort 2 (Placebo)

Arm description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).

Arm type

Placebo

Investigational medicinal product name

Placebo matching to R10933+R10987

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of placebo matching to R10933+R10987 intravenously on Day 1

Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)

Arm description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 2400 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 2400 mg IV R10933+R10987 intravenously on Day 1

Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)

Arm description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 8000 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 8000 mg IV R10933+R10987 intravenously on Day 1

Phase 2: Cohort 3 (Placebo)

Arm description

Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).

Arm type

Placebo

Investigational medicinal product name

Placebo matching to R10933+R10987

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of placebo matching to R10933+R10987 intravenously on Day 1

Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)

Arm description

Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 2400 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 2400 mg IV R10933+R10987 intravenously on Day 1

Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)

Arm description

Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Arm type

Experimental

Investigational medicinal product name

R10933+R10987 8000 mg IV

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

single dose of 8000 mg IV R10933+R10987 intravenously on Day 1

Number of subjects in period 1	Phase 1: Cohort 1 (Placebo)	Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)	Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)	Phase 2: Cohort 1 (Placebo)	Phase 2: Cohort 1 (R10933+R10987 2400 mg	Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)	Phase 3: Cohort 1 (Placebo)	Phase 3: Cohort 1 (R10933+R10987 2400 mg)	Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)	Phase 2: Cohort 1A (Placebo)	Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)	Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)	Phase 2: Cohort 2 (Placebo)	Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)	Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)	Phase 2: Cohort 3 (Placebo)	Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)	Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)
Started	18	18	20	204	206	205	247	246	246	198	202	197	51	56	54	12	12	11
Completed	13	12	16	146	153	148	186	195	189	157	165	166	33	28	31	5	4	7
Not completed	5	6	4	58	53	57	61	51	57	41	37	31	18	28	23	7	8	4
Adverse event, serious fatal	2	-	1	27	25	21	42	23	37	14	8	7	13	25	19	7	8	4
Participant Decision	1	2	2	12	18	22	13	13	10	15	16	17	2	1	2	-	-	-
Physician decision	-	-	-	-	-	-	-	-	-	1	-	-	1	-	-	-	-	-
Adverse event, non-fatal	-	-	-	-	-	-	-	1	-	-	1	1	-	-	-	-	-	-
Lost to follow-up	2	4	1	19	10	14	5	14	10	11	12	6	2	2	2	-	-	-
Sponsor Request	-	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-

Baseline characteristics

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Reporting group title

Phase 1: Cohort 1 (Placebo)

Reporting group description

Reporting group title

Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)

Reporting group description

Reporting group title

Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)

Reporting group description

Reporting group title

Phase 2: Cohort 1 (Placebo)

Reporting group description

Reporting group title

Phase 2: Cohort 1 (R10933+R10987 2400 mg

Reporting group description

Reporting group title

Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)

Reporting group description

Reporting group title

Phase 3: Cohort 1 (Placebo)

Reporting group description

Reporting group title

Phase 3: Cohort 1 (R10933+R10987 2400 mg)

Reporting group description

Reporting group title

Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)

Reporting group description

Reporting group title

Phase 2: Cohort 1A (Placebo)

Reporting group description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).

Reporting group title

Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)

Reporting group description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).

Reporting group title

Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)

Reporting group description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).

Reporting group title

Phase 2: Cohort 2 (Placebo)

Reporting group description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).

Reporting group title

Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)

Reporting group description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Reporting group title

Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)

Reporting group description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Reporting group title

Phase 2: Cohort 3 (Placebo)

Reporting group description

Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).

Reporting group title

Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)

Reporting group description

Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Reporting group title

Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)

Reporting group description

Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Reporting group values	Phase 1: Cohort 1 (Placebo)	Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)	Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)	Phase 2: Cohort 1 (Placebo)	Phase 2: Cohort 1 (R10933+R10987 2400 mg	Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)	Phase 3: Cohort 1 (Placebo)	Phase 3: Cohort 1 (R10933+R10987 2400 mg)	Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)	Phase 2: Cohort 1A (Placebo)	Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)	Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)	Phase 2: Cohort 2 (Placebo)	Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)	Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)	Phase 2: Cohort 3 (Placebo)	Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)	Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)	Total
Number of subjects	18	18	20	204	206	205	247	246	246	198	202	197	51	56	54	12	12	11	2203
Age Categorical
Units: participants
Age: 18- <40 years	1	1	2	26	16	17	29	28	14	22	20	20	4	4	6	0	1	1	212
Age: 40- <65 years	9	8	10	82	99	96	105	119	127	82	101	91	30	23	24	6	4	5	1021
Age: >=65 years	8	9	8	96	91	92	113	99	105	94	81	86	17	29	24	6	7	5	970
Sex: Female, Male
Units: participants
Female	8	8	10	90	98	98	113	112	115	91	87	89	17	20	20	8	4	2	990
Male	10	10	10	114	108	107	134	134	131	107	115	108	34	36	34	4	8	9	1213
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	12	7	10	49	50	52	92	94	82	38	53	40	13	22	18	6	5	4	647
Not Hispanic or Latino	6	11	10	144	148	146	146	140	155	148	138	143	35	33	30	6	7	7	1453
Unknown or Not Reported	0	0	0	11	8	7	9	12	9	12	11	14	3	1	6	0	0	0	103
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	1	1	2	9	9	13	0	0	0	1	0	0	0	0	0	36
Asian	0	2	0	6	7	6	6	10	9	11	8	6	2	2	1	1	1	0	78
Native Hawaiian or Other Pacific Islander	0	0	0	2	1	1	0	1	1	0	0	1	1	1	0	1	0	0	10
Black or African American	3	2	8	34	21	33	26	32	25	27	32	25	7	6	9	1	1	3	295
White	12	11	11	136	146	134	159	151	158	111	116	131	33	39	36	8	9	5	1406
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	3	3	1	25	30	29	47	43	40	49	46	34	7	8	8	1	1	3	378

End points

Top of page

Reporting group title

Phase 1: Cohort 1 (Placebo)

Reporting group description

Reporting group title

Phase 1: Cohort 1 (R10933+R10987 2400 mg IV)

Reporting group description

Reporting group title

Phase 1: Cohort 1 (R10933+R10987 8000 mg IV)

Reporting group description

Reporting group title

Phase 2: Cohort 1 (Placebo)

Reporting group description

Reporting group title

Phase 2: Cohort 1 (R10933+R10987 2400 mg

Reporting group description

Reporting group title

Phase 2: Cohort 1 (R10933+R10987 8000 mg IV)

Reporting group description

Reporting group title

Phase 3: Cohort 1 (Placebo)

Reporting group description

Reporting group title

Phase 3: Cohort 1 (R10933+R10987 2400 mg)

Reporting group description

Reporting group title

Phase 3: Cohort 1 (R10933+R10987 8000 mg IV)

Reporting group description

Reporting group title

Phase 2: Cohort 1A (Placebo)

Reporting group description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 1A).

Reporting group title

Phase 2: Cohort 1A (R10933+R10987 2400 mg IV)

Reporting group description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).

Reporting group title

Phase 2: Cohort 1A (R10933+R10987 8000 mg IV)

Reporting group description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).

Reporting group title

Phase 2: Cohort 2 (Placebo)

Reporting group description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).

Reporting group title

Phase 2: Cohort 2 (R10933+R10987 2400 mg IV)

Reporting group description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Reporting group title

Phase 2: Cohort 2 (R10933+R10987 8000 mg IV)

Reporting group description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Reporting group title

Phase 2: Cohort 3 (Placebo)

Reporting group description

Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).

Reporting group title

Phase 2: Cohort 3 (R10933+R10987 2400 mg IV)

Reporting group description

Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Reporting group title

Phase 2: Cohort 3 (R10933+R10987 8000 mg IV)

Reporting group description

Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Subject analysis set title

Ph.2 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1)

Subject analysis set title

Ph.3 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1.

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of matching placebo intravenously on Day 1 in Phase 2 (Cohort 1A).

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 3 (Cohort 1) and participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1 in Phase 2 (Cohort 1A).

Subject analysis set title

Pooled Ph.3 Cohort 1+ Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1+ Ph.2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Phase 3 Cohort 1 + Phase 2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Phase 2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Phase 2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled R10933+R10987 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single dose of R10933+R10987 2400 mg intravenously on Day 1

Subject analysis set title

Pooled R10933+R10987 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single dose of R10933+R10987 8000 mg intravenously on Day 1.

Subject analysis set title

Pooled Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single dose of R10933+R10987 (2400 mg and 8000 mg) intravenously on Day 1

Subject analysis set title

Pooled R10933+R10987 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single dose of R10933+R10987 8000 mg intravenously on Day 1

Subject analysis set title

Phase 3 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 Cohort 1: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 Cohort 1: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg or 8000mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 2 Cohort 1A: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 Cohort 1A: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A

Subject analysis set title

Phase 2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 3 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 Cohort 1: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 Cohort 1: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 Cohort 1A: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A

Subject analysis set title

Phase 2 Cohort 1A: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 3 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1

Subject analysis set title

Phase 3 Cohort 1: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1

Subject analysis set title

Phase 3 Cohort 1: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 Cohort 1A: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 Cohort 1A: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A

Subject analysis set title

Phase 3 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 Cohort 1: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 Cohort 1: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 Cohort 1A: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 Cohort 1A: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A

Subject analysis set title

Phase 2: Cohort 1A Combined R10933+R10987

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 (2400 mg or 8000 mg) intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 3 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 Cohort 1: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1

Subject analysis set title

Phase 3 Cohort 1: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 Cohort 1A: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV) Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A

Subject analysis set title

Phase 2 Cohort 1A: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 Cohort 1A: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 Cohort 1A: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 Cohort 1A: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1

Subject analysis set title

Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1.

Subject analysis set title

Phase 3 (Cohort 1): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Cohort 1A

Subject analysis set title

Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg or 8000 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Cohort 1A.

Subject analysis set title

Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1

Subject analysis set title

Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1

Subject analysis set title

Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of 2400mg or 8000 mg R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of placebo matching R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled(Ph1C1 and Ph2C1): R10933+R10987(2400mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (2400 mg) intravenously on Day 1

Subject analysis set title

Pooled (Ph1C1 and Ph2C1): R10933+R10987 (8000 mg IV)

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 (8000 mg) intravenously on Day 1

Subject analysis set title

Ph1C1 and Ph2C1: Combined R10933+R10987 IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of 2400mg or 8000 mg R10933+R10987 intravenously on Day 1

Subject analysis set title

Phase 1 [Cohort 1]: R10983+10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 2400 mg intravenously on Day 1

Subject analysis set title

Phase 1 [Cohort 1]: R10983+10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with O2 saturation > 93% on low-flow oxygen via nasal cannula, simple face mask, or other similar device received single dose of R10933+R10987 8000 mg intravenously on Day 1

Subject analysis set title

Phase 1 [Cohort 1]: R10983+10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 1 [Cohort 1]: R10983+10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).

Subject analysis set title

Phase 2 (Cohort 1): R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 1): R10933+R10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 2): R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Subject analysis set title

Phase 2 (Cohort 2): R10933+R10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Subject analysis set title

Phase 2 (Cohort 3): R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Subject analysis set title

Phase 2 (Cohort 3): R10933+R10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 1 [Cohort 1]: R10983+10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 1 [Cohort 1]: R10983+10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 1A).

Subject analysis set title

Phase 2 (Cohort 1A): R10933+R10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants with COVID-19 symptoms but not requiring supplemental oxygen received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 1A).

Subject analysis set title

Phase 2 (Cohort 1): R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 1): R10933+R10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 2 (Cohort 2): R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Subject analysis set title

Phase 2 (Cohort 2): R10933+R10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Subject analysis set title

Phase 2 (Cohort 3): R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Subject analysis set title

Phase 2 (Cohort 3): R10933+R10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Phase 3 (Cohort 1): R10933+R10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Pooled Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single 2400mg intravenous dose of R10933+R10987

Subject analysis set title

Pooled REGN10933+REGN10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single 8000 mg intravenous dose of R10933+R10987

Subject analysis set title

Pooled Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single intravenous dose of placebo matching R10933+R10987

Subject analysis set title

Pooled R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single 2400mg dose of R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled REGN10933+REGN10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single 8000 mg dose of R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled (Phase 2/3) Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants received single dose of placebo matching to R10933+R10987 intravenously on Day 1

Subject analysis set title

Pooled (Phase 2/3) R10933+R10987 2400mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single 2400mg intravenous dose of R10933+R10987

Subject analysis set title

Pooled (Phase 2/3) REGN10933+REGN10987 8000mg IV

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single 8000 mg intravenous dose of R10933+R10987

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS

End point description

Time-weighted average daily change from Day 1 to Day 7 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

End point type

Primary

End point timeframe

Day 1 to Day 7

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	131	150	160	310
Units: log10 copies/milliliter (mL)
least squares mean (standard error)	-1.03 ( 0.10 )	-1.28 ( 0.09 )	-1.34 ( 0.09 )	-1.31 ( 0.06 )

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo

Number of subjects included in analysis

281

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0663 ^[1]

Method

ANCOVA

Parameter type

Least Square (LS) Mean Difference

Point estimate

-0.25

Confidence interval

level

95%

sides

2-sided

lower limit

-0.51

upper limit

0.02

Notes
[1] - P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.

Placebo vs. Combined

Statistical analysis description

To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0172 ^[2]

Method

ANCOVA

Parameter type

Least Square (LS) Mean Difference

Point estimate

-0.28

Confidence interval

level

95%

sides

2-sided

lower limit

-0.51

upper limit

-0.05

Notes
[2] - P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

291

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0204 ^[3]

Method

ANCOVA

Parameter type

Least Square (LS) Mean Difference

Point estimate

-0.31

Confidence interval

level

95%

sides

2-sided

lower limit

-0.57

upper limit

0.05

Notes
[3] - P-value for change from baseline on log scale for each treatment group was based on the Analysis of covariance (ANCOVA) model with treatment group.

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS

End point description

Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on high viral load mFAS were reported.

End point type

Primary

End point timeframe

Day 6 to Day 29

End point values	Pooled Ph.3 Cohort 1+ Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	211	220	225	445
Units: Percentage of Participants
number (confidence interval 95%)	13.3 (9.0 to 18.6)	7.3 (4.2 to 11.5)	12.4 (8.4 to 17.5)	9.9 (7.3 to 13.0)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1+ Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

431

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0431 ^[4]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[4] - P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Placebo vs. Combined

Statistical analysis description

To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.

Comparison groups

Pooled Ph.3 Cohort 1+ Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

656

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2048 ^[5]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[5] - P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1+ Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

436

Analysis specification

Pre-specified

Analysis type

P-value

= 0.7975 ^[6]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[6] - P-value was derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 through Day 29 Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 through Day 29 Based on Seronegative mFAS

End point description

Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on seronegative mFAS were reported.

End point type

Primary

End point timeframe

Day 6 to Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1+ Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	147	162	179	341
Units: Percentage of Participants
number (confidence interval 95%)	15.0 (9.6 to 21.8)	4.9 (2.2 to 9.5)	10.6 (6.5 to 16.1)	7.9 (5.3 to 11.3)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1+ Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

309

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0039 ^[7]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[7] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Placebo vs. Combined

Statistical analysis description

To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

488

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0195 ^[8]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[8] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

326

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2415 ^[9]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[9] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on overall mFAS

Top of page

End point title

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on overall mFAS

End point description

Percentage of participants who died or went on mechanical ventilation from Day 6 through Day 29 based on overall FAS were reported.

End point type

Primary

End point timeframe

Day 6 to Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Phase 3 Cohort 1 + Phase 2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Phase 2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	367	387	383	770
Units: Percentage of Participants
number (confidence interval 95%)	10.6 (7.7 to 14.2)	5.4 (3.4 to 8.2)	10.7 (7.8 to 14.2)	8.1 (6.2 to 10.2)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Phase 3 Cohort 1 + Phase 2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

754

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0085 ^[10]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[10] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Statistical analysis description

To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

1137

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1486 ^[11]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[11] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Phase 2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

750

Analysis specification

Pre-specified

Analysis type

P-value

= 0.9902 ^[12]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[12] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS

End point description

Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on high viral load mFAS were reported.

End point type

Primary

End point timeframe

Day 1 to Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	229	231	236	467
Units: Percentage of Participants
number (confidence interval 95%)	18.8 (13.9 to 24.4)	10.0 (6.4 to 14.6)	14.4 (10.2 to 19.5)	12.2 (9.4 to 15.5)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

460

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0092 ^[13]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[13] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Placebo vs. Combined

Statistical analysis description

To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

696

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0249 ^[14]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[14] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

465

Analysis specification

Pre-specified

Analysis type

P-value

= 0.221 ^[15]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[15] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS

End point description

Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on seronegative mFAS were reported.

End point type

Primary

End point timeframe

Day 1 to Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	160	172	188	360
Units: Percentage of Participants
number (confidence interval 95%)	19.4 (13.6 to 26.4)	8.1 (4.5 to 13.3)	12.2 (7.9 to 17.8)	10.3 (7.3 to 13.9)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

332

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0045 ^[16]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[16] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Placebo vs. Combined

Statistical analysis description

To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

520

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0061 ^[17]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[17] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

348

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0714 ^[18]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[18] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS

Top of page

End point title

Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS

End point description

Percentage of participants who died or went on mechanical ventilation from Day 1 through Day 29 based on overall mFAS were reported.

End point type

Primary

End point timeframe

Day 1 to Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Phase 2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	393	406	398	804
Units: Percentage of Participants
number (confidence interval 95%)	14.8 (11.4 to 18.7)	7.9 (5.5 to 10.9)	12.6 (9.5 to 16.2)	10.2 (8.2 to 12.5)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Phase 2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

799

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0023 ^[19]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[19] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Placebo vs. Combined

Statistical analysis description

To control alpha at a strict 0.05 level, this endpoint was tested hierarchically, with the virologic endpoint tested first. All hierarchical testing was done using the combined dose group.

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

1197

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0212 ^[20]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[20] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

791

Analysis specification

Pre-specified

Analysis type

P-value

= 0.3544 ^[21]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[21] - P-value was derived CMH test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < = 5 or n(1-p) <= 5 in any treatment group, p-value was based on Fisher Exact Test.

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Treatment-Emergent Serious Adverse Events

Top of page

End point title

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Treatment-Emergent Serious Adverse Events ^[22]

End point description

Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the observation period.

End point type

Primary

End point timeframe

Up to Day 169

Notes
[22] - 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 analyses for this end point

End point values	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined
Number of subjects analysed	222	224	225	449
Units: Participants	54	45	47	92

No statistical analyses for this end point

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Grade >=2 Infusion Related Reactions up to Day 4

Top of page

End point title

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Grade >=2 Infusion Related Reactions up to Day 4 ^[23]

End point description

Infusion-related reactions are defined as any relevant adverse event that occurs during the infusion or up to day 4. The severity of adverse events (including test findings classified as adverse events) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).

End point type

Primary

End point timeframe

Up to Day 4

Notes
[23] - 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 analyses for this end point

End point values	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined
Number of subjects analysed	222	224	225	449
Units: Participants	3	2	6	8

No statistical analyses for this end point

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Grade >=2 Hypersensitivity Reactions Up to Day 29

Top of page

End point title

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Grade >=2 Hypersensitivity Reactions Up to Day 29 ^[24]

End point description

Hypersensitivity reactions are defined as any relevant adverse event that occurs during the infusion or up to study day 29. The severity of adverse events (including test findings classified as adverse events) were graded according to NCI-CTCAE.

End point type

Primary

End point timeframe

Up to Day 29

Notes
[24] - 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 analyses for this end point

End point values	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined
Number of subjects analysed	222	224	225	449
Units: Participants	1	2	2	4

No statistical analyses for this end point

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS ^[25]

End point description

Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Primary

End point timeframe

Up to Day 29

Notes
[25] - 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: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined
Number of subjects analysed	32	46	41	87
Units: Cumulative Incidence Percentage
number (confidence interval 80%)	23.0 (16.9 to 30.9)	15.1 (10.5 to 21.4)	20.3 (14.7 to 27.8)	17.6 (13.8 to 22.3)

No statistical analyses for this end point

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS ^[26]

End point description

Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Primary

End point timeframe

Up to Day 29

Notes
[26] - 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 analyses for this end point

End point values	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined
Number of subjects analysed	50	53	58	111
Units: Cumulative Incidence Percentage
number (confidence interval 80%)	20.7 (15.7 to 26.9)	18.9 (14.3 to 24.8)	11.6 (8.0 to 16.8)	15.3 (12.2 to 19.0)

No statistical analyses for this end point

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

End point description

Percentage of participants who went on mechanical ventilation by Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

End point type

Secondary

End point timeframe

by Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	229	231	236	467
Units: Percentage of Participants
number (confidence interval 95%)	11.4 (7.6 to 16.2)	6.1 (3.4 to 10.0)	8.5 (5.3 to 12.8)	7.3 (5.1 to 10.0)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

460

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0575 ^[27]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[27] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

696

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0849 ^[28]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[28] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

465

Analysis specification

Pre-specified

Analysis type

P-value

= 0.3133 ^[29]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[29] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS

End point description

Percentage of participants who went on mechanical ventilation at Day 29 based on Seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

End point type

Secondary

End point timeframe

by Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	160	172	188	360
Units: Percentage of Participants
number (confidence interval 95%)	10.0 (5.8 to 15.7)	5.8 (2.8 to 10.4)	7.4 (4.1 to 12.2)	6.7 (4.3 to 9.8)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

332

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2167 ^[30]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[30] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

520

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2206 ^[31]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[31] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

348

Analysis specification

Pre-specified

Analysis type

P-value

= 0.4123 ^[32]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[32] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS

End point description

Percentage of participants who died from Day 6 through Day 29 based on high viral load mFAS were reported.

End point type

Secondary

End point timeframe

Day 6 to Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	222	226	228	454
Units: Percentage of Participants
number (confidence interval 95%)	13.1 (8.9 to 18.2)	7.1 (4.1 to 11.2)	10.1 (6.5 to 14.8)	8.6 (6.2 to 11.6)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

448

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0383 ^[33]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[33] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

676

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0766 ^[34]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[34] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

450

Analysis specification

Pre-specified

Analysis type

P-value

= 0.3296 ^[35]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[35] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS

End point description

Percentage of participants who died from Day 6 through Day 29 Based on seronegative mFAS in pooled analysis phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.

End point type

Secondary

End point timeframe

Day 6 to Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	153	167	181	348
Units: Percentage of Participants
number (confidence interval 95%)	13.7 (8.7 to 20.2)	4.8 (2.1 to 9.2)	7.2 (3.9 to 12.0)	6.0 (3.8 to 9.1)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

320

Analysis specification

Pre-specified

Analysis type

P-value

= 0.007 ^[36]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[36] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

501

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0051 ^[37]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[37] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

334

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0507 ^[38]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[38] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS

End point description

Percentage of participants who died from Day 1 through Day 29 based on High Viral Load mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.

End point type

Secondary

End point timeframe

Day 1 to Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	229	231	236	467
Units: Percentage of participants
number (confidence interval 95%)	14.4 (10.1 to 19.6)	7.4 (4.3 to 11.5)	11.0 (7.3 to 15.7)	9.2 (6.7 to 12.2)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

460

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0174 ^[39]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[39] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

696

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0454 ^[40]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[40] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

465

Analysis specification

Pre-specified

Analysis type

P-value

= 0.29 ^[41]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[41] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS

End point description

Percentage of participants who died from Day 1 through Day 29 based on seronegative mFAS in pooled analysis phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.

End point type

Secondary

End point timeframe

Day 1 to Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	160	172	188	360
Units: Percentage of Participants
number (confidence interval 95%)	15.0 (9.9 to 21.5)	5.2 (2.4 to 9.7)	8.0 (4.5 to 12.8)	6.7 (4.3 to 9.8)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

332

Analysis specification

Pre-specified

Analysis type

P-value

= 0.004 ^[42]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[42] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

520

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0032 ^[43]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[43] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

348

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0413 ^[44]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[44] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS

End point description

Percentage of participants who were discharged by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.

End point type

Secondary

End point timeframe

by Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	229	231	236	467
Units: Percentage of Participants
number (confidence interval 95%)	80.3 (74.6 to 85.3)	89.2 (84.4 to 92.9)	86.9 (81.9 to 90.9)	88.0 (84.7 to 90.8)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

460

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0105 ^[45]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[45] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

465

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0622 ^[46]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[46] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

696

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0088 ^[47]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[47] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants who Were Discharged by Day 29 Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants who Were Discharged by Day 29 Based on Seronegative mFAS

End point description

Percentage of participants who were discharged by Day 29 based on seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported.

End point type

Secondary

End point timeframe

by Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	160	172	188	360
Units: Percentage of Participants
number (confidence interval 95%)	81.3 (74.3 to 87.0)	90.1 (84.6 to 94.1)	89.9 (84.7 to 93.8)	90.0 (86.4 to 92.9)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

332

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0275 ^[48]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[48] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

520

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0072 ^[49]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[49] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

348

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0223 ^[50]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[50] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS

End point description

Percentage of participants who died or were readmitted to hospital over time based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A)were reported. Readmission to hospital was based on investigator report.

End point type

Secondary

End point timeframe

Up to Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	229	231	236	467
Units: Percentage of Participants
number (confidence interval 95%)	21.0 (15.9 to 26.8)	15.2 (10.8 to 20.4)	17.4 (12.8 to 22.8)	16.3 (13.0 to 19.9)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

460

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1032 ^[51]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[51] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

696

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1314 ^[52]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[52] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

465

Analysis specification

Pre-specified

Analysis type

P-value

= 0.335 ^[53]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[53] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS

End point description

Percentage of participants who died or were readmitted to hospital at Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Readmission to hospital was based on investigator report.

End point type

Secondary

End point timeframe

by Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	160	172	188	360
Units: Percentage of Participants
number (confidence interval 95%)	24.4 (17.9 to 31.8)	11.6 (7.2 to 17.4)	12.8 (8.4 to 18.4)	12.2 (9.0 to 16.1)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

332

Analysis specification

Pre-specified

Analysis type

P-value

= 0.00024 ^[54]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[54] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

520

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0005 ^[55]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[55] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

348

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0054 ^[56]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[56] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS

End point description

Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

by Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	181	201	190	391
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	14.9 (10.8 to 20.3)	7.7 (4.8 to 12.1)	11.7 (8.1 to 16.7)	9.7 (7.3 to 12.9)

No statistical analyses for this end point

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS

End point description

Overall Survival was defined as time interval from randomization to death. Percentage of participants with cumulative incidence of death (ie, overall survival) at Day 29 from randomization based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A)were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

by Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	160	121	148	308
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	8.4 (5.1 to 13.5)	15.8 (10.9 to 22.7)	5.6 (3.0 to 10.5)	7.0 (4.8 to 10.3)

No statistical analyses for this end point

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

End point description

Number of participants with cumulative incidence of mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

by Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	170	194	183	377
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	11.8 (8.2 to 16.8)	6.3 (3.7 to 10.3)	9.1 (6.0 to 13.8)	7.7 (5.5 to 10.6)

No statistical analyses for this end point

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS

End point description

Percentage of participants with cumulative incidence of mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

by Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	114	143	152	295
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	10.6 (6.6 to 16.8)	6.0 (3.3 to 11.0)	7.9 (4.8 to 13.0)	7.0 (4.8 to 10.3)

No statistical analyses for this end point

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

End point description

Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

by Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	170	194	183	377
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	19.1 (14.6 to 24.9)	10.2 (6.9 to 15.0)	15.0 (11.0 to 20.4)	12.7 (9.9 to 16.1)

No statistical analyses for this end point

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS

End point description

Percentage of participants with cumulative incidence of death or mechanical ventilation by Day 29 based on seronegative mFAS in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

by Day 29

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	114	143	152	295
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	20.1 (14.6 to 27.3)	8.4 (5.1 to 13.8)	12.7 (8.7 to 18.6)	10.7 (7.9 to 14.5)

No statistical analyses for this end point

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS

End point description

Time to discharge from hospital based on High Viral Load mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.

End point type

Secondary

End point timeframe

Up to Day 56

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	229	231	236	467
Units: Days
median (confidence interval 95%)	5.0 (4.0 to 6.0)	4.0 (4.0 to 5.0)	4.0 (3.0 to 5.0)	4.0 (4.0 to 5.0)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

460

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0533 ^[57]

Method

Logrank

Confidence interval

Notes
[57] - P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

696

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0229 ^[58]

Method

Logrank

Confidence interval

Notes
[58] - P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

465

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0411 ^[59]

Method

Logrank

Confidence interval

Notes
[59] - P-value based on stratified log-rank test with the type of background standard-of-care and baseline serostatus as stratification factors.

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS

Top of page

End point title

Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS

End point description

Time to discharge from hospital based on Seronegative mFAS in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) was reported.

End point type

Secondary

End point timeframe

Up to Day 56

End point values	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV	Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined
Number of subjects analysed	160	172	188	360
Units: Days
median (confidence interval 95%)	4.5 (4.0 to 6.0)	4.0 (3.0 to 5.0)	4.0 (3.0 to 4.0)	4.0 (3.0 to 4.0)

Placebo vs. 2400mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 2400mg IV

Number of subjects included in analysis

332

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0218

Method

Stratified Log Rank Test

Confidence interval

Placebo vs. Combined

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Combined

Number of subjects included in analysis

520

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0067

Method

Stratified Log Rank Test

Confidence interval

Placebo vs. 8000mg IV

Comparison groups

Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: Placebo v Pooled Ph.3 Cohort 1 + Ph.2 Cohort 1A: 8000mg IV

Number of subjects included in analysis

348

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0156

Method

Stratified Log Rank Test

Confidence interval

Secondary: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Treatment-Emergent Serious Adverse Events

Top of page

End point title

Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Treatment-Emergent Serious Adverse Events

End point description

End point type

Secondary

End point timeframe

Up to Day 169

End point values	Pooled Placebo	Pooled R10933+R10987 2400 mg IV	Pooled R10933+R10987 8000 mg IV	Pooled Combined R10933+R10987 IV
Number of subjects analysed	730	740	733	1473
Units: Participants	203	177	181	358

No statistical analyses for this end point

Secondary: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Grade >=2 Infusion Related Reactions up to Day 4

Top of page

End point title

Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Grade >=2 Infusion Related Reactions up to Day 4

End point description

End point type

Secondary

End point timeframe

Up to Day 4

End point values	Pooled Placebo	Pooled R10933+R10987 2400 mg IV	Pooled R10933+R10987 8000 mg IV	Pooled Combined R10933+R10987 IV
Number of subjects analysed	730	740	733	1473
Units: Participants	6	11	15	26

No statistical analyses for this end point

Secondary: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Grade >=2 Hypersensitivity Reactions Up to Day 29

Top of page

End point title

Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Grade >=2 Hypersensitivity Reactions Up to Day 29

End point description

End point type

Secondary

End point timeframe

Up to Day 29

End point values	Pooled Placebo	Pooled R10933+R10987 2400 mg IV	Pooled R10933+R10987 8000 mg IV	Pooled Combined R10933+R10987 IV
Number of subjects analysed	730	740	733	1473
Units: Participants	2	5	7	12

No statistical analyses for this end point

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS ^[60]

End point description

Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

End point type

Secondary

End point timeframe

by Day 29

Notes
[60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 Cohort 1: 2400 mg IV	Phase 3 Cohort 1: 8000 mg IV	Phase 3 Cohort 1: Combined	Phase 2 Cohort 1A: 2400 mg IV	Phase 2 Cohort 1A: 8000 mg IV	Phase 2 Cohort 1A: Combined
Number of subjects analysed	70	90	80	82	162	92	106	198
Units: Percentage of Participants
number (confidence interval 95%)	17.1 (9.2 to 28.0)	4.4 (1.2 to 11.0)	8.8 (3.6 to 17.2)	17.1 (9.7 to 27.0)	13.0 (8.2 to 19.1)	3.3 (0.7 to 9.2)	0.0 (0.0 to 0.0)	1.5 (0.3 to 4.4)

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 2400 mg IV

Number of subjects included in analysis

150

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2162 ^[61]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[61] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs, Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: Combined

Number of subjects included in analysis

288

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2103 ^[62]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[62] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 2400 mg IV

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

P-value

= 0.7189 ^[63]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[63] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 8000 mg IV

Number of subjects included in analysis

196

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0429 ^[64]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[64] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 8000 mg IV

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

P-value

= 0.8783 ^[65]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[65] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: Combined

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

P-value

= 0.5583 ^[66]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[66] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 through Day 29 Based on Seronegative mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 through Day 29 Based on Seronegative mFAS ^[67]

End point description

Percentage of participants who died from Day 6 through Day 29 in phase 3 (cohort 1) and phase 2 (cohort 1A) were reported.

End point type

Secondary

End point timeframe

Day 6 to Day 29

Notes
[67] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 Cohort 1: 2400 mg IV	Phase 3 Cohort 1: 8000 mg IV	Phase 3 Cohort 1: Combined	Phase 2 Cohort 1A: 2400 mg IV	Phase 2 Cohort 1A: 8000 mg IV	Phase 2 Cohort 1A: Combined
Number of subjects analysed	67	86	79	80	159	88	101	189
Units: Percentage of Participants
number (confidence interval 95%)	19.4 (10.8 to 30.9)	9.3 (4.1 to 17.5)	6.3 (2.1 to 14.2)	10.0 (4.4 to 13.6)	8.2 (4.4 to 13.6)	3.4 (0.7 to 9.6)	5.0 (1.6 to 11.2)	4.2 (1.8 to 8.2)

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 2400 mg IV

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0223 ^[68]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[68] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 8000 mg IV

Number of subjects included in analysis

147

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1256 ^[69]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[69] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: Combined

Number of subjects included in analysis

226

Analysis specification

Pre-specified

Analysis type

P-value

= 0.023 ^[70]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[70] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 2400 mg IV

Number of subjects included in analysis

174

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1298 ^[71]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[71] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 8000 mg IV

Number of subjects included in analysis

187

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2642 ^[72]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[72] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: Combined

Number of subjects included in analysis

275

Analysis specification

Pre-specified

Analysis type

P-value

= 0.097 ^[73]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[73] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS ^[74]

End point description

Percentage of participants who died from Day 1 through Day 29 in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.

End point type

Secondary

End point timeframe

Day 1 to Day 29

Notes
[74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 Cohort 1: 2400 mg IV	Phase 3 Cohort 1: 8000 mg IV	Phase 3 Cohort 1: Combined	Phase 2 Cohort 1A: 2400 mg IV	Phase 2 Cohort 1A: 8000 mg IV	Phase 2 Cohort 1A: Combined
Number of subjects analysed	70	90	80	82	162	92	106	198
Units: Percentage of Participants
number (confidence interval 95%)	22.9 (13.7 to 34.4)	8.9 (3.9 to 16.8)	7.5 (2.8 to 15.6)	11.0 (5.1 to 19.8)	9.3 (5.3 to 14.8)	3.3 (0.7 to 9.2)	5.7 (2.1 to 11.9)	4.5 (2.1 to 8.5)

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 2400 mg IV

Number of subjects included in analysis

150

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0147 ^[75]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[75] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 8000 mg IV

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0669 ^[76]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[76] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: Combined

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0094 ^[77]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[77] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 2400 mg IV

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1306 ^[78]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[78] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 8000 mg IV

Number of subjects included in analysis

196

Analysis specification

Pre-specified

Analysis type

P-value

= 0.3576 ^[79]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[79] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: Combined

Number of subjects included in analysis

288

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1476 ^[80]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[80] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on Seronegative mFAS ^[81]

End point description

Percentage of participants who were discharged in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported.

End point type

Secondary

End point timeframe

by Day 29

Notes
[81] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 Cohort 1: 2400 mg IV	Phase 3 Cohort 1: 8000 mg IV	Phase 3 Cohort 1: Combined	Phase 2 Cohort 1A: 2400 mg IV	Phase 2 Cohort 1A: 8000 mg IV	Phase 2 Cohort 1A: Combined
Number of subjects analysed	70	90	80	82	162	92	106	198
Units: Percentage of Participants
number (confidence interval 95%)	70.0 (57.9 to 80.4)	90.0 (81.9 to 95.3)	85.0 (75.3 to 92.0)	84.1 (74.4 to 91.3)	84.6 (78.1 to 89.8)	94.6 (87.8 to 98.2)	94.3 (88.1 to 97.9)	94.4 (90.3 to 97.2)

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 2400 mg IV

Number of subjects included in analysis

150

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0481 ^[82]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[82] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 8000 mg IV

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0535 ^[83]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[83] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 8000 mg IV

Number of subjects included in analysis

196

Analysis specification

Pre-specified

Analysis type

P-value

= 0.251 ^[84]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[84] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 2400 mg IV

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2784 ^[85]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[85] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: Combined

Number of subjects included in analysis

288

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1702 ^[86]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[86] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: Combined

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0199 ^[87]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[87] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS ^[88]

End point description

Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) by Day 29 were reported. Readmission to hospital was based on investigator report.

End point type

Secondary

End point timeframe

Up to Day 29

Notes
[88] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 Cohort 1: 2400 mg IV	Phase 3 Cohort 1: 8000 mg IV	Phase 3 Cohort 1: Combined	Phase 2 Cohort 1A: 2400 mg IV	Phase 2 Cohort 1A: 8000 mg IV	Phase 2 Cohort 1A: Combined
Number of subjects analysed	70	90	80	82	162	92	106	198
Units: Percentage of Participants
number (confidence interval 95%)	27.1 (17.2 to 39.1)	22.2 (14.1 to 32.2)	13.8 (7.1 to 23.3)	14.6 (7.8 to 24.2)	14.2 (9.2 to 20.5)	9.8 (4.6 to 17.8)	11.3 (6.0 to 18.9)	10.6 (6.7 to 15.8)

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 2400 mg IV

Number of subjects included in analysis

150

Analysis specification

Pre-specified

Analysis type

P-value

= 0.05 ^[89]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[89] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 8000 mg IV

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0663 ^[90]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[90] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: Combined

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0229 ^[91]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[91] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 2400 mg IV

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0208 ^[92]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[92] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 8000 mg IV

Number of subjects included in analysis

196

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0388 ^[93]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[93] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: Combined

Number of subjects included in analysis

288

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0092 ^[94]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[94] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death up to Day 29 Based on Seronegative mFAS ^[95]

End point description

Percentage of participants with cumulative incidence of death in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) up to Day 29 from randomization were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

Up to Day 29

Notes
[95] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 Cohort 1: 2400 mg IV	Phase 3 Cohort 1: 8000 mg IV	Phase 3 Cohort 1: Combined	Phase 2 Cohort 1A: 2400 mg IV	Phase 2 Cohort 1A: 8000 mg IV	Phase 2: Cohort 1A Combined R10933+R10987
Number of subjects analysed	51	70	70	70	140	78	90	168
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	23.6 (15.1 to 35.6)	9.6 (4.9 to 18.3)	7.8 (3.6 to 16.5)	11.4 (6.1 to 20.7)	9.6 (5.9 to 15.4)	3.6 (1.2 to 10.9)	5.9 (2.7 to 12.8)	4.8 (2.6 to 9.1)

No statistical analyses for this end point

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS ^[96]

End point description

Percentage of participants with cumulative incidence of mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

by Day 29

Notes
[96] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 2 Cohort 1A: 8000 mg IV	Phase 3 Cohort 1: 2400 mg IV	Phase 3 Cohort 1: 8000 mg IV	Phase 3 Cohort 1: Combined	Phase 2 Cohort 1A: 2400 mg IV	Phase 2 Cohort 1A: Combined
Number of subjects analysed	46	68	90	66	62	128	77	167
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	18.2 (10.8 to 30.0)	4.7 (1.8 to 12.1)	0.0 (0.0 to 0.0)	8.9 (4.4 to 17.8)	17.6 (10.8 to 27.9)	13.4 (8.9 to 19.8)	3.5 (1.1 to 10.5)	1.7 (0.5 to 5.1)

No statistical analyses for this end point

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS ^[97]

End point description

Percentage of participants with cumulative incidence of death or mechanical ventilation in Phase 3 (Cohort 1) and Phase 2 (Cohort 1A) by Day 29 were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

by Day 29

Notes
[97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 2 Cohort 1A: 8000 mg IV	Phase 3 Cohort 1: 2400 mg IV	Phase 3 Cohort 1: 8000 mg IV	Phase 3 Cohort 1: Combined	Phase 2 Cohort 1A: 2400 mg IV	Phase 2 Cohort 1A: Combined
Number of subjects analysed	46	68	90	66	62	128	77	167
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	30.4 (21.0 to 42.7)	11.8 (6.5 to 20.8)	5.9 (2.7 to 12.8)	12.7 (7.0 to 22.3)	21.2 (13.8 to 31.9)	17.0 (12.0 to 23.8)	4.7 (1.8 to 12.1)	5.4 (2.9 to 9.7)

No statistical analyses for this end point

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS ^[98]

End point description

Time to discharge from hospital up to Day 56 was reported.

End point type

Secondary

End point timeframe

Up to Day 56

Notes
[98] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 Cohort 1: 2400 mg IV	Phase 3 Cohort 1: 8000 mg IV	Phase 3 Cohort 1: Combined	Phase 2 Cohort 1A: Combined	Phase 2 Cohort 1A: 2400 mg IV	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Number of subjects analysed	70	90	80	82	162	198	86	99
Units: Days
median (confidence interval 95%)	8.5 (5.0 to 15.0)	4.0 (3.0 to 4.0)	5.0 (4.0 to 7.0)	6.0 (4.0 to 9.0)	6.0 (4.0 to 7.0)	3.0 (2.0 to 4.0)	3.0 (2.0 to 4.0)	3.0 (2.0 to 4.0)

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 2400 mg IV

Number of subjects included in analysis

150

Analysis specification

Pre-specified

Analysis type

P-value

= 0.037

Method

stratified log-rank test

Confidence interval

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 8000 mg IV

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1596

Method

stratified log-rank test

Confidence interval

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

189

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0407

Method

stratified log-rank test

Confidence interval

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 2400 mg IV

Number of subjects included in analysis

176

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1802

Method

stratified log-rank test

Confidence interval

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: Combined

Number of subjects included in analysis

288

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0523

Method

stratified log-rank test

Confidence interval

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: Combined

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0444

Method

stratified log-rank test

Confidence interval

Secondary: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS

Top of page

End point title

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 11 Based on Seronegative mFAS ^[99]

End point description

TWA change from baseline in viral load up to Day 11 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 11, was measured by RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.

End point type

Secondary

End point timeframe

Day 1 to Day 11

Notes
[99] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 2 Cohort 1A: Combined	Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): Combined R10933+R10987 IV	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)
Number of subjects analysed	59	80	167	76	78	154	79	88
Units: log10 copies/mL
least squares mean (standard error)	-1.52 ( 0.17 )	-1.28 ( 0.14 )	-1.95 ( 0.10 )	-2.03 ( 0.15 )	-1.95 ( 0.15 )	-2.00 ( 0.10 )	-1.88 ( 0.14 )	-2.01 ( 0.14 )

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

135

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0245

Method

ANCOVA

Confidence interval

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

137

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0554

Method

ANCOVA

Confidence interval

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): Combined R10933+R10987 IV

Number of subjects included in analysis

213

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0179

Method

ANCOVA

Confidence interval

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

159

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0035

Method

ANCOVA

Confidence interval

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

168

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0003

Method

ANCOVA

Confidence interval

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: Combined

Number of subjects included in analysis

247

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0002

Method

ANCOVA

Confidence interval

Secondary: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29

Top of page

End point title

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: TWA Change From Baseline Viral Load (Seronegative mFAS) in NP Samples up to Day 29 ^[100]

End point description

TWA change from baseline in viral load up to Day 29 was calculated for each participant using the trapezoidal rule as the area under the curve for change from baseline at each time point divided by the time interval for the observation period. TWA change from baseline viral load in NP samples through Day 29, was measured by quantitative RT-qPCR in NP swab samples was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicate improvement in viral load.

End point type

Secondary

End point timeframe

Day 1 to Day 29

Notes
[100] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): Combined R10933+R10987 IV	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Number of subjects analysed	64	84	77	79	156	82	93	175
Units: log10 copies/mL
least squares mean (standard error)	-2.72 ( 0.22 )	-2.66 ( 0.21 )	-3.68 ( 0.20 )	-3.69 ( 0.20 )	-3.69 ( 0.14 )	-3.31 ( 0.21 )	-3.58 ( 0.20 )	-3.45 ( 0.14 )

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

141

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0013

Method

ANCOVA

Confidence interval

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Number of subjects included in analysis

259

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0014

Method

ANCOVA

Confidence interval

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

166

Analysis specification

Pre-specified

Analysis type

P-value

= 0.025

Method

ANCOVA

Confidence interval

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0012

Method

ANCOVA

Confidence interval

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

143

Analysis specification

Pre-specified

Analysis type

P-value

= 0.001

Method

ANCOVA

Confidence interval

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): Combined R10933+R10987 IV

Number of subjects included in analysis

220

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0002

Method

ANCOVA

Confidence interval

Secondary: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time

Top of page

End point title

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time ^[101]

End point description

Change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.

End point type

Secondary

End point timeframe

Days 3, 5, 7, 9, 11, 13, 15, 22 and 29

Notes
[101] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 Cohort 1: 2400 mg IV	Phase 3 Cohort 1: 8000 mg IV	Phase 3 Cohort 1: Combined	Phase 2 Cohort 1A: 2400 mg IV	Phase 2 Cohort 1A: 8000 mg IV	Phase 2 Cohort 1A: Combined
Number of subjects analysed	70	90	80	82	162	92	106	198
Units: log10 copies/mL
least squares mean (standard error)
Change at Day 3	-1.10 ( 0.22 )	-0.85 ( 0.21 )	-0.90 ( 0.19 )	-0.93 ( 0.19 )	-0.92 ( 0.14 )	-1.03 ( 0.20 )	-1.41 ( 0.19 )	-1.23 ( 0.14 )
Change at Day 5	-1.97 ( 0.27 )	-1.55 ( 0.25 )	-2.28 ( 0.23 )	-1.91 ( 0.25 )	-2.11 ( 0.17 )	-2.21 ( 0.26 )	-2.24 ( 0.24 )	-2.21 ( 0.18 )
Change at Day 7	-1.97 ( 0.30 )	-2.29 ( 0.26 )	-2.92 ( 0.26 )	-3.22 ( 0.25 )	-3.09 ( 0.18 )	-3.06 ( 0.25 )	-3.49 ( 0.24 )	-3.27 ( 0.17 )
Change at Day 9	-2.56 ( 0.32 )	-2.90 ( 0.28 )	-3.89 ( 0.27 )	-4.16 ( 0.27 )	-4.03 ( 0.19 )	-3.75 ( 0.26 )	-3.85 ( 0.24 )	-3.80 ( 0.18 )
Change at Day 11	-3.22 ( 0.35 )	-3.88 ( 0.32 )	-4.23 ( 0.29 )	-4.57 ( 0.30 )	-4.41 ( 0.21 )	-4.76 ( 0.30 )	-4.34 ( 0.27 )	-4.52 ( 0.2 )
Change at Day 13	-3.76 ( 0.35 )	-4.22 ( 0.31 )	-5.18 ( 0.30 )	-5.00 ( 0.29 )	-5.10 ( 0.21 )	-4.56 ( 0.29 )	-5.05 ( 0.27 )	-4.82 ( 0.20 )
Change at Day 15	-4.42 ( 0.32 )	-4.14 ( 0.28 )	-5.41 ( 0.28 )	-5.25 ( 0.27 )	-5.34 ( 0.19 )	-5.03 ( 0.27 )	-5.23 ( 0.25 )	-5.14 ( 0.18 )
Change at Day 22	-5.29 ( 0.30 )	-5.37 ( 0.30 )	-5.74 ( 0.24 )	-5.95 ( 0.24 )	-5.85 ( 0.17 )	-5.75 ( 0.29 )	-5.77 ( 0.25 )	-5.75 ( 0.19 )
Change at Day 29	-5.90 ( 0.24 )	-5.77 ( 0.27 )	-6.46 ( 0.18 )	-6.60 ( 0.18 )	-6.54 ( 0.13 )	-6.34 ( 0.26 )	-6.36 ( 0.23 )	-6.35 ( 0.17 )

Difference vs. Placebo by Day 29

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 2400 mg IV

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1206

Method

MMRM

Confidence interval

Difference vs. Placebo by Day 29

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 8000 mg IV

Number of subjects included in analysis

196

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0911

Method

MMRM

Confidence interval

Difference vs. Placebo by Day 29

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: Combined

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0193

Method

MMRM

Confidence interval

Difference vs. Placebo by Day 29

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 2400 mg IV

Number of subjects included in analysis

150

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0623

Method

MMRM

Confidence interval

Difference vs. Placebo by Day 29

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 8000 mg IV

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0203

Method

MMRM

Confidence interval

Difference vs. Placebo by Day 29

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: Combined

Number of subjects included in analysis

288

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0645

Method

MMRM

Confidence interval

Secondary: Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time

Top of page

End point title

Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]: Percent Change From Baseline in Viral Load (Seronegative mFAS) as Measured by RT-qPCR in NP Swabs Over Time ^[102]

End point description

Percent change from baseline in viral load as measured by RT-qPCR in NP swabs over time was reported. Baseline was defined as the last non-missing value measured prior to dosing. Negative changes indicates improvement in viral load.

End point type

Secondary

End point timeframe

Days 3, 5, 7, 9, 11, 13, 15, 22 and 29

Notes
[102] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 Cohort 1: 2400 mg IV	Phase 3 Cohort 1: 8000 mg IV	Phase 3 Cohort 1: Combined	Phase 2 Cohort 1A: 2400 mg IV	Phase 2 Cohort 1A: 8000 mg IV	Phase 2 Cohort 1A: Combined
Number of subjects analysed	70	90	80	82	162	92	106	198
Units: Percent Change
least squares mean (confidence interval 95%)
Percent change at Day 3	-92.04 (-97.12 to -78.01)	-85.92 (-94.47 to -64.12)	-87.52 (-94.82 to -69.93)	-88.15 (-95.07 to -71.52)	-87.94 (-93.51 to -77.61)	-90.65 (-96.19 to -77.01)	-96.15 (-98.37 to -90.90)	-94.15 (-96.86 to -89.09)
Percent change at Day 5	-98.92 (-99.68 to -96.35)	-97.18 (-99.09 to -91.23)	-99.48 (-99.82 to -98.50)	-98.76 (-99.59 to -96.20)	-99.23 (-99.64 to -98.34)	-99.38 (-99.81 to -97.96)	-99.42 (-99.81 to -98.26)	-99.39 (-99.73 to -98.63)
Percent change at Day 7	-98.92 (-99.73 to -95.76)	-99.49 (-99.84 to -98.36)	-99.88 (-99.96 to -99.62)	-99.94 (-99.98 to -99.82)	-99.92 (-99.96 to -99.82)	-99.91 (-99.97 to -99.73)	-99.97 (-99.99 to -99.90)	-99.95 (-99.98 to -99.88)
Percent change at Day 9	-99.72 (-99.94 to -98.80)	-99.87 (-99.96 to -99.56)	-99.99 (-100.00 to -99.96)	-99.99 (-100.00 to -99.98)	-99.99 (-100.00 to -99.98)	-99.98 (-99.99 to -99.94)	-99.99 (-100.00 to -99.96)	-99.98 (-99.99 to -99.97)
Percent change at Day 11	-99.94 (-99.99 to -99.70)	-99.99 (-100.00 to -99.94)	-99.99 (-100.00 to -99.98)	-100.00 (-100.00 to -99.99)	-100.00 (-100.00 to -99.99)	-100.00 (-100.00 to -99.99)	-100.00 (-100.00 to -99.98)	-100.00 (-100.00 to -99.99)
Percent change at Day 13	-99.98 (-100.00 to -99.91)	-99.99 (-100.00 to -99.98)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -99.99)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)
Percent change at Day 15	-100.00 (-100.00 to -99.98)	-99.99 (-100.00 to -99.97)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)
Percent change at Day 22	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)
Percent change at Day 29	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)	-100.00 (-100.00 to -100.00)

Percent Difference vs. Placebo at Day 29

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 2400 mg IV

Number of subjects included in analysis

150

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0623

Method

MMRM

Confidence interval

Percent Difference vs. Placebo at Day 29

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: 8000 mg IV

Number of subjects included in analysis

152

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0203

Method

MMRM

Confidence interval

Percent Difference vs. Placebo at Day 29

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: Combined

Number of subjects included in analysis

288

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0645

Method

MMRM

Confidence interval

Percent Difference vs. Placebo at Day 29

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 2400 mg IV

Number of subjects included in analysis

182

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1206

Method

MMRM

Confidence interval

Percent Difference vs. Placebo at Day 29

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 Cohort 1A: 8000 mg IV

Number of subjects included in analysis

196

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0911

Method

MMRM

Confidence interval

Percent Difference vs. Placebo at Day 29

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 Cohort 1: Combined

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0193

Method

MMRM

Confidence interval

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS ^[103]

End point description

Percentage of participants who went on mechanical ventilation in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

End point type

Secondary

End point timeframe

by Day 29

Notes
[103] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): Combined R10933+R10987 IV	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Number of subjects analysed	126	103	129	118	247	102	118	220
Units: Percentage of Participants
number (confidence interval 95%)	17.5 (11.3 to 25.2)	3.9 (1.1 to 9.6)	8.5 (4.3 to 14.7)	16.9 (10.7 to 25.0)	12.6 (8.7 to 17.3)	2.9 (0.6 to 8.4)	0.0 (0.0 to 0.0)	1.4 (0.3 to 3.9)

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

255

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0481 ^[104]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[104] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

244

Analysis specification

Pre-specified

Analysis type

P-value

= 0.988 ^[105]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[105] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

221

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0457 ^[106]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[106] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

205

Analysis specification

Pre-specified

Analysis type

P-value

= 1 ^[107]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[107] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Number of subjects included in analysis

323

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2153 ^[108]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[108] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): Combined R10933+R10987 IV

Number of subjects included in analysis

373

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2498 ^[109]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[109] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died from Day 6 to Day 29 Based on High Viral Load mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died from Day 6 to Day 29 Based on High Viral Load mFAS ^[110]

End point description

Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

End point type

Secondary

End point timeframe

Day 6 to Day 29

Notes
[110] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): Combined R10933+R10987 IV	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Number of subjects analysed	122	100	128	115	243	98	113	211
Units: Percentage of Participants
number (confidence interval 95%)	18.0 (11.7 to 26.0)	7.0 (2.9 to 13.9)	10.2 (5.5 to 16.7)	15.7 (9.5 to 23.6)	12.8 (8.8 to 17.6)	3.1 (0.6 to 8.7)	4.4 (1.5 to 10.0)	3.8 (1.7 to 7.3)

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

250

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0811 ^[111]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[111] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

237

Analysis specification

Pre-specified

Analysis type

P-value

= 0.6701 ^[112]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[112] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): Combined R10933+R10987 IV

Number of subjects included in analysis

365

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2006 ^[113]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[113] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

198

Analysis specification

Pre-specified

Analysis type

P-value

= 0.3313 ^[114]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[114] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

213

Analysis specification

Pre-specified

Analysis type

P-value

= 0.5542 ^[115]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[115] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Number of subjects included in analysis

311

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2214 ^[116]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[116] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died from Day 1 to Day 29 Based on High Viral Load mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died from Day 1 to Day 29 Based on High Viral Load mFAS ^[117]

End point description

Percentage of participants who died in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

End point type

Secondary

End point timeframe

Day 1 to Day 29

Notes
[117] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): Combined R10933+R10987 IV	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Number of subjects analysed	126	103	129	118	247	102	118	220
Units: Percentage of Participants
number (confidence interval 95%)	20.6 (13.9 to 28.8)	6.8 (2.8 to 13.5)	10.9 (6.1 to 17.5)	16.9 (10.7 to 25.0)	13.8 (9.7 to 18.7)	2.9 (0.6 to 8.4)	5.1 (1.9 to 10.7)	4.1 (1.9 to 7.6)

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

255

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0389 ^[118]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[118] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Number of subjects included in analysis

323

Analysis specification

Pre-specified

Analysis type

P-value

= 0.3036 ^[119]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[119] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

205

Analysis specification

Pre-specified

Analysis type

P-value

= 0.3315 ^[120]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[120] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

221

Analysis specification

Pre-specified

Analysis type

P-value

= 0.5797 ^[121]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[121] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

244

Analysis specification

Pre-specified

Analysis type

P-value

= 0.5208 ^[122]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[122] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): Combined R10933+R10987 IV

Number of subjects included in analysis

373

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1079 ^[123]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[123] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS ^[124]

End point description

Percentage of participants who were discharged in phase 3 (Cohort 1) and phase 2 (Cohort 1A) was reported.

End point type

Secondary

End point timeframe

by Day 29

Notes
[124] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): Combined R10933+R10987 IV	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Number of subjects analysed	126	103	129	118	247	102	118	220
Units: Percentage of Participants
number (confidence interval 95%)	72.2 (63.5 to 79.8)	90.3 (82.9 to 95.2)	83.7 (76.2 to 89.6)	78.8 (70.3 to 85.8)	81.4 (76.0 to 86.0)	96.1 (90.3 to 98.9)	94.9 (89.3 to 98.1)	95.5 (91.8 to 97.8)

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

255

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0364 ^[125]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[125] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

244

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2795 ^[126]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[126] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): Combined R10933+R10987 IV

Number of subjects included in analysis

373

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0588 ^[127]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[127] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

205

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0364 ^[128]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[128] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

221

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2795 ^[129]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[129] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Number of subjects included in analysis

323

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0588 ^[130]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[130] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS

Top of page

End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS ^[131]

End point description

Percentage of participants who died or were readmitted to hospital in phase 3 (Cohort 1) and phase 2 (Cohort 1A) over time were reported. Readmission to hospital was based on investigator report.

End point type

Secondary

End point timeframe

Up to Day 29

Notes
[131] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): Combined R10933+R10987 IV	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Number of subjects analysed	126	103	129	118	247	102	118	220
Units: Percentage of Participants
number (confidence interval 95%)	24.6 (17.4 to 33.1)	16.5 (9.9 to 25.1)	18.6 (12.3 to 26.4)	22.9 (15.7 to 31.5)	20.6 (15.8 to 26.2)	10.8 (5.5 to 18.5)	11.9 (6.6 to 19.1)	11.4 (7.5 to 16.3)

Placebo vs. 2400mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

255

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2635 ^[132]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[132] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

244

Analysis specification

Pre-specified

Analysis type

P-value

= 0.8013 ^[133]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[133] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): Combined R10933+R10987 IV

Number of subjects included in analysis

323

Analysis specification

Pre-specified

Analysis type

P-value

= 0.1981 ^[134]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[134] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 2400mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)

Number of subjects included in analysis

205

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2194 ^[135]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[135] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. 8000mg IV

Comparison groups

Phase 2: Cohort 1A (Placebo) v Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)

Number of subjects included in analysis

221

Analysis specification

Pre-specified

Analysis type

P-value

= 0.324 ^[136]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[136] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Placebo vs. Combined

Comparison groups

Phase 3: Cohort 1 (Placebo) v Phase 3 (Cohort 1): Combined R10933+R10987 IV

Number of subjects included in analysis

373

Analysis specification

Pre-specified

Analysis type

P-value

= 0.416 ^[137]

Method

Cochran-Mantel-Haenszel

Confidence interval

Notes
[137] - P-value is derived Cochran-Mantel-Haenszel (CMH) test stratified by the type of background standard-of-care (antiviral therapies and non-antiviral therapies). If np < =5 or n(1-p) <= 5 in any treatment group, p-value is based on Fisher Exact Test.

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS

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End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death Over Time Based on High Viral Load mFAS ^[138]

End point description

Cumulative Incidence of Death Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

Up to Day 29

Notes
[138] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): Combined R10933+R10987 IV	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Number of subjects analysed	96	85	110	90	200	91	100	191
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	21.1 (14.9 to 29.4)	7.2 (3.5 to 14.4)	11.2 (6.8 to 18.2)	17.9 (11.9 to 26.3)	14.3 (10.5 to 19.5)	3.1 (1.0 to 9.4)	5.3 (2.4 to 11.5)	4.3 (2.3 to 8.2)

No statistical analyses for this end point

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS

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End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation Over Time Based on High Viral Load mFAS ^[139]

End point description

Cumulative Incidence of Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

Up to Day 29

Notes
[139] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): Combined R10933+R10987 IV	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Number of subjects analysed	87	83	100	104	83	187	90	190
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	18.1 (12.3 to 26.2)	4.0 (1.5 to 10.4)	0.0 (0.0 to 0.0)	8.8 (5.0 to 15.3)	18.0 (12.0 to 26.5)	13.1 (9.4 to 18.1)	3.1 (1.0 to 9.2)	1.5 (0.5 to 4.5)

No statistical analyses for this end point

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS

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End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation Over Time Based on High Viral Load mFAS ^[140]

End point description

Cumulative Incidence of Death or Mechanical Ventilation Over Time in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported. Cumulative incidence percentage was estimated using Kaplan-Meier method.

End point type

Secondary

End point timeframe

Up to Day 29

Notes
[140] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): Combined R10933+R10987 IV	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Number of subjects analysed	87	83	100	104	83	187	90	190
Units: Cumulative Incidence Percentage
number (confidence interval 95%)	27.2 (20.2 to 35.9)	9.1 (4.9 to 16.8)	5.3 (2.4 to 11.5)	15.0 (9.8 to 22.5)	24.4 (17.6 to 33.4)	19.5 (15.0 to 25.1)	4.1 (1.6 to 10.5)	4.8 (2.6 to 8.7)

No statistical analyses for this end point

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS

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End point title

Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge Based on High Viral Load mFAS ^[141]

End point description

Time to Discharge in phase 3 (Cohort 1) and phase 2 (Cohort 1A) were reported.

End point type

Secondary

End point timeframe

Up to Day 56

Notes
[141] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only applicable to participants in specified phases/cohorts

End point values	Phase 3: Cohort 1 (Placebo)	Phase 2: Cohort 1A (Placebo)	Phase 3 (Cohort 1): R10933+R10987 (2400 mg IV)	Phase 3 (Cohort 1): R10933+R10987 (8000 mg IV)	Phase 3 (Cohort 1): Combined R10933+R10987 IV	Phase 2 (Cohort 1A): R10933+R10987 (2400 mg IV)	Phase 2 (Cohort 1A): R10933+R10987 (8000 mg IV)	Phase 2 (Cohort 1A): Combined R10933+R10987 IV
Number of subjects analysed	126	103	129	118	247	102	118	220
Units: days
median (confidence interval 95%)	7.0 (5.0 to 10.0)	4.0 (3.0 to 4.0)	7.0 (5.0 to 8.0)	7.0 (5.0 to 8.0)	7.0 (6.0 to 8.0)	3.0 (2.0 to 4.0)	3.0 (2.0 to 3.0)	3.0 (3.0 to 3.0)

No statistical analyses for this end point

Secondary: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS

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End point title

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Over Time Based on Seronegative mFAS

End point description

Time-weighted average daily change over time up to Day 29 in viral load (log10 copies/mL), as measured by reverse transcription quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal (NP) swab samples.

End point type

Secondary

End point timeframe

Up to Day 29

End point values	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV	Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined
Number of subjects analysed	68	79	70	149
Units: log10 copies/milliliter (mL)
least squares mean (standard error)
TWA change from BL: Day 1 to Day 3	-0.33 ( 0.11 )	-0.40 ( 0.11 )	-0.60 ( 0.12 )	-0.50 ( 0.08 )
TWA change from BL: Day 1 to Day 5	-0.55 ( 0.14 )	-0.86 ( 0.14 )	-0.92 ( 0.14 )	-0.89 ( 0.10 )
TWA change from BL: Day 1 to Day 7	-0.70 ( 0.14 )	-1.23 ( 0.14 )	-1.23 ( 0.14 )	-1.23 ( 0.10 )
TWA change from BL: Day 1 to Day 9	-0.93 ( 0.16 )	-1.47 ( 0.15 )	-1.58 ( 0.16 )	-1.52 ( 0.11 )
TWA change from BL: Day 1 to Day 11	-1.12 ( 0.16 )	-1.72 ( 0.16 )	-1.78 ( 0.17 )	-1.75 ( 0.12 )
TWA change from BL: Day 1 to Day 13	-1.33 ( 0.18 )	-1.96 ( 0.17 )	-1.95 ( 0.18 )	-1.96 ( 0.12 )
TWA change from BL: Day 1 to Day 15	-1.50 ( 0.19 )	-2.19 ( 0.18 )	-2.16 ( 0.19 )	-2.18 ( 0.13 )
TWA change from BL: Day 1 to Day 22	-1.89 ( 0.22 )	-2.62 ( 0.21 )	-2.64 ( 0.22 )	-2.63 ( 0.15 )
TWA change from BL: Day 1 to Day 29	-2.35 ( 0.24 )	-2.98 ( 0.23 )	-2.95 ( 0.24 )	-2.97 ( 0.17 )

No statistical analyses for this end point

Secondary: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS

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End point title

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Change From Baseline as Measured by RT-qPCR in NP Swabs Over Time Based on Seronegative mFAS

End point description

End point type

Secondary

End point timeframe

Days 3, 5, 7, 9, 11, 13, 15, 22 and 29

End point values	Pooled (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Placebo	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV	Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined
Number of subjects analysed	68	79	70	149
Units: log10 copies/milliliter (mL)
least squares mean (standard error)
TWA change from BL: Day 1 to Day 3	-0.66 ( 0.22 )	-0.81 ( 0.21 )	-1.08 ( 0.23 )	-0.94 ( 0.16 )
TWA change from BL: Day 1 to Day 5	-1.18 ( 0.26 )	-2.08 ( 0.26 )	-2.28 ( 0.27 )	-2.18 ( 0.19 )
TWA change from BL: Day 1 to Day 7	-1.62 ( 0.30 )	-2.76 ( 0.27 )	-2.56 ( 0.29 )	-2.67 ( 0.20 )
TWA change from BL: Day 1 to Day 9	-2.68 ( 0.34 )	-3.24 ( 0.31 )	-3.16 ( 0.32 )	-3.20 ( 0.22 )
TWA change from BL: Day 1 to Day 11	-3.55 ( 0.39 )	-3.74 ( 0.38 )	-3.94 ( 0.37 )	-3.87 ( 0.26 )
TWA change from BL: Day 1 to Day 13	-3.04 ( 0.38 )	-5.01 ( 0.35 )	-4.25 ( 0.39 )	-4.68 ( 0.26 )
TWA change from BL: Day 1 to Day 15	-4.60 ( 0.39 )	-4.67 ( 0.35 )	-5.01 ( 0.36 )	-4.84 ( 0.25 )
TWA change from BL: Day 1 to Day 22	-5.89 ( 0.37 )	-5.21 ( 0.31 )	-5.25 ( 0.32 )	-5.23 ( 0.22 )
TWA change from BL: Day 1 to Day 29	-6.01 ( 0.32 )	-6.04 ( 0.27 )	-6.16 ( 0.28 )	-6.10 ( 0.20 )

No statistical analyses for this end point

Secondary: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Top of page

End point title

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on Seronegative mFAS

End point description

End point type

Secondary

End point timeframe

Through Day 29

End point values	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 2400 mg IV	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: 8000 mg IV	Ph.1 Cohort 1 + Ph.2 Cohort 1: Combined
Number of subjects analysed	52	62	59	121
Units: Percentage of Participants
number (confidence interval 80%)	26.9 (19.0 to 34.8)	17.7 (11.5 to 24.0)	22.0 (15.1 to 28.9)	19.8 (15.2 to 24.5)

No statistical analyses for this end point

Secondary: Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Top of page

End point title

Phase 1 [Cohort 1] and Phase 2 [Cohort 1]: Percentage of Participants Who Died or Went On Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

End point description

End point type

Secondary

End point timeframe

Through Day 29

End point values	Pooled Ph.1 Cohort 1 + Ph.2 Cohort 1: Placebo	Pooled(Ph1C1 and Ph2C1): R10933+R10987(2400mg IV)	Pooled (Ph1C1 and Ph2C1): R10933+R10987 (8000 mg IV)	Ph1C1 and Ph2C1: Combined R10933+R10987 IV
Number of subjects analysed	78	77	80	157
Units: Percentage of Participants
number (confidence interval 80%)	23.1 (17.0 to 29.2)	23.4 (17.2 to 29.6)	13.8 (8.8 to 18.7)	18.5 (14.5 to 22.4)

No statistical analyses for this end point

Secondary: Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve from Time 0 to 28 days Post-dose (AUC0-28)

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End point title

Phase 1 [Cohort 1]: Area Under the Concentration-Time Curve from Time 0 to 28 days Post-dose (AUC0-28)

End point description

End point type

Secondary

End point timeframe

Up to Day 28

End point values	Phase 1 [Cohort 1]: R10983+10987 2400mg IV	Phase 1 [Cohort 1]: R10983+10987 8000mg IV
Number of subjects analysed	16	20
Units: day*mg/L
arithmetic mean (standard deviation)
AUC0-28 of Casirivimab	3026 ( 719 )	9678 ( 3362 )
AUC0-28 of Imdevimab	2582 ( 581 )	8680 ( 2930 )

No statistical analyses for this end point

Secondary: Concentration at the End of Infusion (Ceoi)

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End point title

Concentration at the End of Infusion (Ceoi)

End point description

End point type

Secondary

End point timeframe

Day 1

End point values	Phase 1 [Cohort 1]: R10983+10987 2400mg IV	Phase 1 [Cohort 1]: R10983+10987 8000mg IV	Phase 2 (Cohort 1A): R10933+R10987 2400mg IV	Phase 2 (Cohort 1A): R10933+R10987 8000mg IV	Phase 2 (Cohort 1): R10933+R10987 2400mg IV	Phase 2 (Cohort 1): R10933+R10987 8000mg IV	Phase 2 (Cohort 2): R10933+R10987 2400mg IV	Phase 2 (Cohort 2): R10933+R10987 8000mg IV	Phase 2 (Cohort 3): R10933+R10987 2400mg IV	Phase 2 (Cohort 3): R10933+R10987 8000mg IV	Phase 3 (Cohort 1): R10933+R10987 2400mg IV	Phase 3 (Cohort 1): R10933+R10987 8000mg IV
Number of subjects analysed	16	20	167	155	181	178	55	50	10	11	214	207
Units: milligrams per liter (mg/L)
arithmetic mean (standard deviation)
Ceoi of Casirivimab	231 ( 110 )	776 ( 372 )	272 ( 124 )	847 ( 300 )	288 ( 86.8 )	848 ( 261 )	286 ( 93.5 )	921 ( 262 )	284 ( 69.3 )	708 ( 128 )	307 ( 153 )	908 ( 338 )
Ceoi of Imdevimab	243 ( 117 )	795 ( 371 )	283 ( 127 )	868 ( 298 )	300 ( 87.3 )	880 ( 268 )	302 ( 94.0 )	946 ( 244 )	290 ( 81.7 )	738 ( 124 )	312 ( 157 )	945 ( 351 )

No statistical analyses for this end point

Secondary: Concentration at Day 28 (C28)

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End point title

Concentration at Day 28 (C28)

End point description

End point type

Secondary

End point timeframe

Day 28

End point values	Phase 1 [Cohort 1]: R10983+10987 2400mg IV	Phase 1 [Cohort 1]: R10983+10987 8000mg IV	Phase 2 (Cohort 1A): R10933+R10987 2400mg IV	Phase 2 (Cohort 1A): R10933+R10987 8000mg IV	Phase 2 (Cohort 1): R10933+R10987 2400mg IV	Phase 2 (Cohort 1): R10933+R10987 8000mg IV	Phase 2 (Cohort 2): R10933+R10987 2400mg IV	Phase 2 (Cohort 2): R10933+R10987 8000mg IV	Phase 2 (Cohort 3): R10933+R10987 2400mg IV	Phase 2 (Cohort 3): R10933+R10987 8000mg IV	Phase 3 (Cohort 1): R10933+R10987 2400mg IV	Phase 3 (Cohort 1): R10933+R10987 8000mg IV
Number of subjects analysed	9	9	91	96	91	93	25	26	3	5	149	146
Units: mg/L
arithmetic mean (standard deviation)
C28 of Casirivimab	50.7 ( 19.5 )	166 ( 108 )	64.8 ( 35.9 )	174 ( 65.1 )	50.0 ( 20.4 )	144 ( 89.8 )	26.4 ( 18.5 )	79.4 ( 61.4 )	9.06 ( 2.64 )	67.8 ( 31.1 )	49.1 ( 40.4 )	140 ( 66.1 )
C28 of Imdevimab	36.1 ( 16.1 )	131 ( 84.1 )	54.7 ( 37.6 )	150 ( 62.9 )	39.8 ( 18.9 )	113 ( 68.8 )	18.7 ( 14.7 )	60.0 ( 53.9 )	5.25 ( 4.12 )	52.4 ( 24.7 )	40.8 ( 48.3 )	114 ( 62.6 )

No statistical analyses for this end point

Secondary: Immunogenicity as measured by anti-drug antibodies (ADAs) to REGN10933

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End point title

Immunogenicity as measured by anti-drug antibodies (ADAs) to REGN10933

End point description

End point type

Secondary

End point timeframe

Through Day 169

End point values	Pooled Placebo	Pooled R10933+R10987 2400mg IV	Pooled REGN10933+REGN10987 8000mg IV
Number of subjects analysed	503	504	497
Units: Participants	489	471	484

No statistical analyses for this end point

Secondary: Immunogenicity as measured by anti-drug antibodies (ADAs) to REGN10987

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End point title

Immunogenicity as measured by anti-drug antibodies (ADAs) to REGN10987

End point description

End point type

Secondary

End point timeframe

Through Day 169

End point values	Pooled Placebo	Pooled R10933+R10987 2400mg IV	Pooled REGN10933+REGN10987 8000mg IV
Number of subjects analysed	503	504	497
Units: Participants	467	444	463

No statistical analyses for this end point

Secondary: Immunogenicity as measured by Neutralizing antibody status (NAb) to REGN10933

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End point title

Immunogenicity as measured by Neutralizing antibody status (NAb) to REGN10933

End point description

End point type

Secondary

End point timeframe

Through Day 57

End point values	Pooled (Phase 2/3) Placebo	Pooled (Phase 2/3) R10933+R10987 2400mg IV	Pooled (Phase 2/3) REGN10933+REGN10987 8000mg IV
Number of subjects analysed	503	504	497
Units: Participants
Anti-drug Antibody (ADA) Negative	489	471	484
Neutralizing antibody (NAb) Positive	1	1	1

No statistical analyses for this end point

Secondary: Immunogenicity as measured by Neutralizing antibody status (NAb) to REGN10987

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End point title

Immunogenicity as measured by Neutralizing antibody status (NAb) to REGN10987

End point description

End point type

Secondary

End point timeframe

Through Day 57

End point values	Pooled (Phase 2/3) Placebo	Pooled (Phase 2/3) R10933+R10987 2400mg IV	Pooled (Phase 2/3) REGN10933+REGN10987 8000mg IV
Number of subjects analysed	503	504	497
Units: Participants
Anti-drug Antibody (ADA) Negative	467	444	463
Neutralizing antibody (NAb) Positive	9	10	4

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

From first dose of study drug to Day 169

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Phase 2 Cohort 1A: Placebo IV

Reporting group description

Reporting group title

Phase 1 Cohort 1: Cas+Imdev 8000mg IV

Reporting group description

Reporting group title

Phase 1 Cohort 1: Cas+Imdev 2400mg IV

Reporting group description

Reporting group title

Phase 1 Cohort 1: Placebo IV

Reporting group description

Reporting group title

Phase 2 Cohort 1: Cas+Imdev 2400mg IV

Reporting group description

Reporting group title

Phase 2 Cohort 1: Placebo IV

Reporting group description

Reporting group title

Phase 2 Cohort 1A: Cas+Imdev 8000mg IV

Reporting group description

Reporting group title

Phase 2 Cohort 1A: Cas+Imdev 2400mg IV

Reporting group description

Reporting group title

Phase 2 Cohort 1: Cas+Imdev 8000mg IV

Reporting group description

Reporting group title

Phase 2 Cohort 2: Cas+Imdev 8000mg IV

Reporting group description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Reporting group title

Phase 2 Cohort 2: Cas+Imdev 2400mg IV

Reporting group description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 2).

Reporting group title

Phase 2 Cohort 2: Placebo IV

Reporting group description

Participants on high-flow oxygen therapy but not on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 2).

Reporting group title

Phase 2 Cohort 3: Placebo IV

Reporting group description

Participants on mechanical ventilation received single dose of placebo matching to R10933+R10987 intravenously on Day 1 in Phase 2 (Cohort 3).

Reporting group title

Phase 2 Cohort 3: Cas+Imdev 2400mg IV

Reporting group description

Participants on mechanical ventilation received single dose of R10933+R10987 2400 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Reporting group title

Phase 3 Cohort 1: Cas+Imdev 2400mg IV

Reporting group description

Reporting group title

Phase 3 Cohort 1: Placebo IV

Reporting group description

Reporting group title

Phase 2 Cohort 3: Cas+Imdev 8000mg IV

Reporting group description

Participants on mechanical ventilation received single dose of R10933+R10987 8000 mg intravenously on Day 1 in Phase 2 (Cohort 3).

Reporting group title

Phase 3 Cohort 1: Cas+Imdev 8000mg IV

Reporting group description

Phase 2 Cohort 1A: Placebo IV

Phase 1 Cohort 1: Cas+Imdev 8000mg IV

Phase 1 Cohort 1: Cas+Imdev 2400mg IV

Phase 1 Cohort 1: Placebo IV

Phase 2 Cohort 1: Cas+Imdev 2400mg IV

Phase 2 Cohort 1: Placebo IV

Phase 2 Cohort 1A: Cas+Imdev 8000mg IV

Phase 2 Cohort 1A: Cas+Imdev 2400mg IV

Phase 2 Cohort 1: Cas+Imdev 8000mg IV

Phase 2 Cohort 2: Cas+Imdev 8000mg IV

Phase 2 Cohort 2: Cas+Imdev 2400mg IV

Phase 2 Cohort 2: Placebo IV

Phase 2 Cohort 3: Placebo IV

Phase 2 Cohort 3: Cas+Imdev 2400mg IV

Phase 3 Cohort 1: Cas+Imdev 2400mg IV

Phase 3 Cohort 1: Placebo IV

Phase 2 Cohort 3: Cas+Imdev 8000mg IV

Phase 3 Cohort 1: Cas+Imdev 8000mg IV

Total subjects affected by serious adverse events

subjects affected / exposed

43 / 198 (21.72%)

2 / 20 (10.00%)

3 / 18 (16.67%)

47 / 206 (22.82%)

63 / 204 (30.88%)

32 / 197 (16.24%)

29 / 202 (14.36%)

47 / 205 (22.93%)

26 / 54 (48.15%)

31 / 56 (55.36%)

20 / 51 (39.22%)

9 / 12 (75.00%)

11 / 12 (91.67%)

56 / 246 (22.76%)

65 / 247 (26.32%)

5 / 11 (45.45%)

69 / 246 (28.05%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Appendix cancer

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Chronic myelomonocytic leukaemia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Colon cancer

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Squamous cell carcinoma of skin

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Arteriosclerosis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Deep vein thrombosis

subjects affected / exposed

0 / 198 (0.00%)

1 / 20 (5.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Distributive shock

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Embolism venous

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haematoma

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Haemorrhage

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Hypertensive urgency

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Hypotension

subjects affected / exposed

0 / 198 (0.00%)

1 / 20 (5.00%)

0 / 18 (0.00%)

2 / 206 (0.97%)

2 / 204 (0.98%)

0 / 197 (0.00%)

0 / 202 (0.00%)

2 / 205 (0.98%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypovolaemic shock

subjects affected / exposed

0 / 198 (0.00%)

1 / 20 (5.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Orthostatic hypotension

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Peripheral artery occlusion

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Shock

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Shock haemorrhagic

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

1 / 204 (0.49%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Venous thrombosis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Venous thrombosis limb

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Surgical and medical procedures

Ileostomy closure

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Asthenia

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

2 / 202 (0.99%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

2 / 246 (0.81%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Chest pain

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

2 / 246 (0.81%)

0 / 247 (0.00%)

0 / 11 (0.00%)

2 / 246 (0.81%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 4

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

Chills

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

2 / 12 (16.67%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Death

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

3 / 204 (1.47%)

0 / 197 (0.00%)

2 / 202 (0.99%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

2 / 246 (0.81%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 3

0 / 0

0 / 2

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 3

0 / 0

0 / 2

0 / 1

0 / 0

0 / 2

0 / 0

Fatigue

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Generalised oedema

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Multiple organ dysfunction syndrome

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

1 / 54 (1.85%)

1 / 56 (1.79%)

0 / 51 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

1 / 246 (0.41%)

3 / 247 (1.21%)

0 / 11 (0.00%)

6 / 246 (2.44%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 3

0 / 0

0 / 6

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 3

0 / 0

0 / 6

Non-cardiac chest pain

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pain

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Sudden cardiac death

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

Systemic inflammatory response syndrome

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

Anaphylactic reaction

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypersensitivity

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Lung transplant rejection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Dyspnoea

subjects affected / exposed

2 / 198 (1.01%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

1 / 206 (0.49%)

2 / 204 (0.98%)

3 / 197 (1.52%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

3 / 246 (1.22%)

2 / 247 (0.81%)

0 / 11 (0.00%)

3 / 246 (1.22%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 1

0 / 2

1 / 3

0 / 0

0 / 3

0 / 2

0 / 0

0 / 4

deaths causally related to treatment / all

0 / 0

Hypoxia

subjects affected / exposed

3 / 198 (1.52%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

3 / 206 (1.46%)

7 / 204 (3.43%)

1 / 197 (0.51%)

1 / 202 (0.50%)

7 / 205 (3.41%)

2 / 54 (3.70%)

1 / 56 (1.79%)

1 / 51 (1.96%)

0 / 12 (0.00%)

8 / 246 (3.25%)

8 / 247 (3.24%)

0 / 11 (0.00%)

5 / 246 (2.03%)

occurrences causally related to treatment / all

0 / 3

0 / 0

0 / 1

0 / 3

1 / 9

0 / 1

1 / 1

0 / 7

0 / 2

1 / 1

0 / 1

0 / 0

0 / 8

1 / 9

0 / 0

2 / 6

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

1 / 1

0 / 1

0 / 0

1 / 2

0 / 0

1 / 1

Pneumonitis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Acute respiratory distress syndrome

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

2 / 204 (0.98%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

2 / 54 (3.70%)

4 / 56 (7.14%)

0 / 51 (0.00%)

0 / 12 (0.00%)

3 / 246 (1.22%)

2 / 247 (0.81%)

0 / 11 (0.00%)

2 / 246 (0.81%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 2

0 / 4

0 / 0

0 / 3

0 / 2

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

Acute respiratory failure

subjects affected / exposed

5 / 198 (2.53%)

1 / 20 (5.00%)

0 / 18 (0.00%)

10 / 206 (4.85%)

6 / 204 (2.94%)

2 / 197 (1.02%)

2 / 202 (0.99%)

5 / 205 (2.44%)

3 / 54 (5.56%)

7 / 56 (12.50%)

0 / 51 (0.00%)

2 / 12 (16.67%)

1 / 12 (8.33%)

6 / 246 (2.44%)

11 / 247 (4.45%)

1 / 11 (9.09%)

5 / 246 (2.03%)

occurrences causally related to treatment / all

0 / 5

0 / 1

0 / 0

1 / 10

0 / 6

0 / 2

0 / 5

0 / 3

0 / 7

0 / 0

0 / 2

0 / 1

0 / 6

0 / 12

0 / 1

0 / 6

deaths causally related to treatment / all

0 / 1

0 / 0

1 / 8

0 / 3

0 / 1

0 / 5

0 / 3

0 / 7

0 / 0

0 / 2

0 / 1

0 / 3

0 / 9

0 / 1

0 / 3

Alveolar lung disease

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

Aspiration

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

1 / 11 (9.09%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Asthma

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Atelectasis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Chronic obstructive pulmonary disease

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

2 / 246 (0.81%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 3

deaths causally related to treatment / all

0 / 0

0 / 1

Dyspnoea exertional

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemoptysis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Idiopathic pulmonary fibrosis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Laryngeal stenosis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Organising pneumonia

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pleural effusion

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pleuritic pain

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumomediastinum

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia aspiration

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumothorax

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

2 / 56 (3.57%)

0 / 51 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

1 / 246 (0.41%)

1 / 247 (0.40%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Pneumothorax spontaneous

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary artery thrombosis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Pulmonary embolism

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

5 / 206 (2.43%)

2 / 204 (0.98%)

0 / 197 (0.00%)

2 / 202 (0.99%)

1 / 205 (0.49%)

1 / 54 (1.85%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

2 / 247 (0.81%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 5

0 / 2

0 / 0

0 / 2

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

Pulmonary oedema

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Respiratory arrest

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Respiratory distress

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

1 / 54 (1.85%)

1 / 56 (1.79%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Respiratory failure

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

4 / 206 (1.94%)

9 / 204 (4.41%)

0 / 197 (0.00%)

2 / 202 (0.99%)

6 / 205 (2.93%)

5 / 54 (9.26%)

4 / 56 (7.14%)

5 / 51 (9.80%)

1 / 12 (8.33%)

3 / 12 (25.00%)

7 / 246 (2.85%)

7 / 247 (2.83%)

0 / 11 (0.00%)

5 / 246 (2.03%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 4

0 / 10

0 / 0

0 / 3

2 / 8

0 / 6

0 / 4

0 / 6

0 / 1

0 / 3

0 / 7

0 / 8

0 / 0

0 / 5

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 5

0 / 0

0 / 1

1 / 3

0 / 1

0 / 3

0 / 4

0 / 1

0 / 3

0 / 4

0 / 0

0 / 3

Tachypnoea

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Anxiety

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Confusional state

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Delirium

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Mental status changes

subjects affected / exposed

2 / 198 (1.01%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

2 / 197 (1.02%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

3 / 246 (1.22%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 2

0 / 0

0 / 3

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Product issues

Device occlusion

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Investigations

Blood glucose increased

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ECG signs of myocardial ischaemia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fibrin D dimer increased

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemoglobin decreased

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Hepatic enzyme increased

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Inflammatory marker increased

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

International normalised ratio increased

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Klebsiella test positive

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mean arterial pressure increased

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oxygen saturation decreased

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Injury, poisoning and procedural complications

Acetabulum fracture

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Brain herniation

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Endotracheal intubation complication

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fall

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

2 / 202 (0.99%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

1 / 12 (8.33%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

2 / 246 (0.81%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

Gastrointestinal stoma complication

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Head injury

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Pancreatic leak

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Post procedural complication

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Post procedural haemorrhage

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rib fracture

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Stomal hernia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Subdural haematoma

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Toxicity to various agents

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Acute coronary syndrome

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Acute left ventricular failure

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Acute myocardial infarction

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

2 / 246 (0.81%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

0 / 2

Angina pectoris

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrial fibrillation

subjects affected / exposed

1 / 198 (0.51%)

1 / 20 (5.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

3 / 204 (1.47%)

0 / 197 (0.00%)

1 / 202 (0.50%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 1

0 / 0

0 / 1

0 / 3

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Atrial flutter

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atrial tachycardia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

1 / 56 (1.79%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bradycardia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

1 / 56 (1.79%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Cardiac arrest

subjects affected / exposed

2 / 198 (1.01%)

0 / 20 (0.00%)

0 / 18 (0.00%)

3 / 206 (1.46%)

1 / 204 (0.49%)

1 / 197 (0.51%)

0 / 202 (0.00%)

1 / 205 (0.49%)

3 / 54 (5.56%)

2 / 56 (3.57%)

2 / 51 (3.92%)

0 / 12 (0.00%)

1 / 12 (8.33%)

1 / 246 (0.41%)

2 / 247 (0.81%)

1 / 11 (9.09%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 3

0 / 1

0 / 0

0 / 1

0 / 4

0 / 5

0 / 3

0 / 0

0 / 2

0 / 1

0 / 2

0 / 1

deaths causally related to treatment / all

0 / 2

0 / 0

0 / 3

0 / 0

0 / 1

0 / 2

0 / 1

0 / 0

0 / 1

0 / 0

Cardiac failure

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

2 / 247 (0.81%)

0 / 11 (0.00%)

2 / 246 (0.81%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Cardiac failure acute

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac failure chronic

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac failure congestive

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

2 / 246 (0.81%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

0 / 1

Cardio-respiratory arrest

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

3 / 246 (1.22%)

3 / 247 (1.21%)

0 / 11 (0.00%)

2 / 246 (0.81%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 4

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 2

Cardiogenic shock

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

2 / 247 (0.81%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

Chronic left ventricular failure

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myocardial infarction

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myocarditis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Pulseless electrical activity

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Tachycardia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

2 / 206 (0.97%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ventricular tachycardia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Nervous system disorders

Cerebral haemorrhage

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cerebral infarction

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cerebrovascular accident

subjects affected / exposed

2 / 198 (1.01%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

1 / 54 (1.85%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Dementia Alzheimer's type

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Depressed level of consciousness

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Dizziness

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Encephalopathy

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

2 / 206 (0.97%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

2 / 205 (0.98%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

0 / 2

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Haemorrhage intracranial

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Hydrocephalus

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypoaesthesia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ischaemic stroke

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolic encephalopathy

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

1 / 18 (5.56%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

2 / 246 (0.81%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Multiple sclerosis relapse

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Seizure

subjects affected / exposed

0 / 198 (0.00%)

1 / 20 (5.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Syncope

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

3 / 204 (1.47%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Toxic encephalopathy

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Transverse sinus thrombosis

subjects affected / exposed

0 / 198 (0.00%)

1 / 20 (5.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Unresponsive to stimuli

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Anaemia

subjects affected / exposed

1 / 198 (0.51%)

1 / 20 (5.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

1 / 12 (8.33%)

2 / 246 (0.81%)

2 / 247 (0.81%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 4

0 / 0

deaths causally related to treatment / all

0 / 0

Febrile neutropenia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypercoagulation

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sickle cell anaemia with crisis

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 1

0 / 0

Thrombocytopenia

subjects affected / exposed

1 / 198 (0.51%)

1 / 20 (5.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ear and labyrinth disorders

Vertigo positional

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Blindness unilateral

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal distension

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Abdominal pain

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Abdominal pain upper

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dysphagia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal haemorrhage

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Gastrooesophageal reflux disease

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haematemesis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haematochezia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Ileus

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Impaired gastric emptying

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Intestinal ischaemia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Intestinal obstruction

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lower gastrointestinal haemorrhage

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mallory-Weiss syndrome

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pancreatitis acute

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rectal haemorrhage

subjects affected / exposed

0 / 198 (0.00%)

1 / 20 (5.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Retroperitoneal haematoma

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Retroperitoneal haemorrhage

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

Small intestinal obstruction

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Acute hepatic failure

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Cholelithiasis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatic cirrhosis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Ischaemic hepatitis

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Decubitus ulcer

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pruritus

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Subcutaneous emphysema

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

1 / 56 (1.79%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Acute kidney injury

subjects affected / exposed

1 / 198 (0.51%)

1 / 20 (5.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

2 / 206 (0.97%)

2 / 204 (0.98%)

0 / 197 (0.00%)

1 / 202 (0.50%)

3 / 205 (1.46%)

4 / 54 (7.41%)

1 / 56 (1.79%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

1 / 246 (0.41%)

4 / 247 (1.62%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 1

0 / 2

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 3

0 / 4

0 / 1

0 / 0

0 / 1

0 / 4

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

End stage renal disease

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

Haematuria

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal failure

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

2 / 204 (0.98%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Renal impairment

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

1 / 11 (9.09%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Renal tubular injury

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ureterolithiasis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

1 / 56 (1.79%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Arthralgia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Compartment syndrome

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Muscular weakness

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myalgia

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neck pain

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Infections and infestations

COVID-19

subjects affected / exposed

7 / 198 (3.54%)

1 / 20 (5.00%)

1 / 18 (5.56%)

4 / 206 (1.94%)

6 / 204 (2.94%)

6 / 197 (3.05%)

0 / 202 (0.00%)

7 / 205 (3.41%)

8 / 54 (14.81%)

7 / 56 (12.50%)

4 / 51 (7.84%)

2 / 12 (16.67%)

1 / 12 (8.33%)

5 / 246 (2.03%)

10 / 247 (4.05%)

2 / 11 (18.18%)

8 / 246 (3.25%)

occurrences causally related to treatment / all

0 / 7

0 / 1

0 / 4

0 / 6

0 / 0

0 / 7

0 / 10

0 / 7

0 / 4

0 / 2

0 / 1

0 / 5

0 / 10

0 / 2

0 / 9

deaths causally related to treatment / all

0 / 5

0 / 0

0 / 1

0 / 3

0 / 0

0 / 3

0 / 7

0 / 6

0 / 2

0 / 1

0 / 3

0 / 2

0 / 7

Appendicitis perforated

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Arthritis bacterial

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Aspergillus infection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Burkholderia cepacia complex infection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

COVID-19 pneumonia

subjects affected / exposed

4 / 198 (2.02%)

0 / 20 (0.00%)

0 / 18 (0.00%)

2 / 206 (0.97%)

2 / 204 (0.98%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

3 / 54 (5.56%)

2 / 56 (3.57%)

3 / 51 (5.88%)

0 / 12 (0.00%)

3 / 246 (1.22%)

5 / 247 (2.02%)

0 / 11 (0.00%)

7 / 246 (2.85%)

occurrences causally related to treatment / all

0 / 4

0 / 0

0 / 2

0 / 0

0 / 1

0 / 3

0 / 2

0 / 3

0 / 0

0 / 3

0 / 5

0 / 0

0 / 7

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 3

0 / 2

0 / 3

0 / 0

0 / 3

0 / 0

0 / 3

Candida infection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Candida sepsis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 246 (0.00%)

0 / 247 (0.00%)

1 / 11 (9.09%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cellulitis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cytomegalovirus infection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Device related bacteraemia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

0 / 1

Emphysematous cholecystitis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Encephalitis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Enterococcal infection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Escherichia urinary tract infection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Fungaemia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Herpes simplex

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Herpes zoster

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ophthalmic herpes zoster

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Osteomyelitis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Osteomyelitis fungal

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Perirectal abscess

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumococcal infection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

5 / 204 (2.45%)

1 / 197 (0.51%)

0 / 202 (0.00%)

3 / 205 (1.46%)

1 / 54 (1.85%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

2 / 247 (0.81%)

0 / 11 (0.00%)

3 / 246 (1.22%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 5

0 / 1

0 / 0

0 / 3

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 4

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

Pneumonia bacterial

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

4 / 206 (1.94%)

3 / 204 (1.47%)

0 / 197 (0.00%)

1 / 202 (0.50%)

2 / 205 (0.98%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 4

0 / 3

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia klebsiella

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

1 / 54 (1.85%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia serratia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia staphylococcal

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

1 / 56 (1.79%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Post procedural infection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

1 / 51 (1.96%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pseudomonal sepsis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary sepsis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

3 / 247 (1.21%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 3

0 / 0

Pyelonephritis acute

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Scrotal abscess

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sepsis

subjects affected / exposed

2 / 198 (1.01%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

4 / 204 (1.96%)

0 / 197 (0.00%)

0 / 202 (0.00%)

3 / 205 (1.46%)

0 / 54 (0.00%)

1 / 56 (1.79%)

1 / 51 (1.96%)

0 / 12 (0.00%)

1 / 246 (0.41%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 1

0 / 4

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Septic shock

subjects affected / exposed

1 / 198 (0.51%)

1 / 20 (5.00%)

0 / 18 (0.00%)

2 / 206 (0.97%)

3 / 204 (1.47%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

1 / 54 (1.85%)

2 / 56 (3.57%)

2 / 51 (3.92%)

0 / 12 (0.00%)

2 / 246 (0.81%)

6 / 247 (2.43%)

0 / 11 (0.00%)

5 / 246 (2.03%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 3

0 / 0

0 / 1

0 / 2

0 / 0

0 / 2

0 / 7

0 / 0

0 / 6

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 4

Serratia infection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Staphylococcal bacteraemia

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

1 / 56 (1.79%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Staphylococcal infection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

2 / 51 (3.92%)

0 / 12 (0.00%)

1 / 12 (8.33%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Staphylococcal sepsis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

1 / 11 (9.09%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Superinfection bacterial

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

1 / 56 (1.79%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

2 / 247 (0.81%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

Urinary tract candidiasis

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract infection

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

1 / 18 (5.56%)

0 / 18 (0.00%)

0 / 206 (0.00%)

2 / 204 (0.98%)

2 / 197 (1.02%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract infection enterococcal

subjects affected / exposed

1 / 198 (0.51%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urosepsis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Viral cardiomyopathy

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 12 (8.33%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Viral myocarditis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Metabolism and nutrition disorders

Acidosis

subjects affected / exposed

0 / 198 (0.00%)

1 / 20 (5.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Calciphylaxis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Decreased appetite

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dehydration

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

1 / 202 (0.50%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Failure to thrive

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Hyperglycaemia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hyperkalaemia

subjects affected / exposed

2 / 198 (1.01%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypernatraemia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypervolaemia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypoglycaemia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

1 / 197 (0.51%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

1 / 247 (0.40%)

0 / 11 (0.00%)

1 / 246 (0.41%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Hypokalaemia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

1 / 206 (0.49%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypophosphataemia

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

1 / 246 (0.41%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolic acidosis

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

0 / 204 (0.00%)

0 / 197 (0.00%)

0 / 202 (0.00%)

1 / 205 (0.49%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Type 2 diabetes mellitus

subjects affected / exposed

0 / 198 (0.00%)

0 / 20 (0.00%)

0 / 18 (0.00%)

0 / 206 (0.00%)

1 / 204 (0.49%)

0 / 197 (0.00%)

0 / 202 (0.00%)

0 / 205 (0.00%)

0 / 54 (0.00%)

0 / 56 (0.00%)

0 / 51 (0.00%)

0 / 12 (0.00%)

0 / 246 (0.00%)

0 / 247 (0.00%)

0 / 11 (0.00%)

0 / 246 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	Phase 2 Cohort 1A: Placebo IV	Phase 1 Cohort 1: Cas+Imdev 8000mg IV	Phase 1 Cohort 1: Cas+Imdev 2400mg IV	Phase 1 Cohort 1: Placebo IV	Phase 2 Cohort 1: Cas+Imdev 2400mg IV	Phase 2 Cohort 1: Placebo IV	Phase 2 Cohort 1A: Cas+Imdev 8000mg IV	Phase 2 Cohort 1A: Cas+Imdev 2400mg IV	Phase 2 Cohort 1: Cas+Imdev 8000mg IV	Phase 2 Cohort 2: Cas+Imdev 8000mg IV	Phase 2 Cohort 2: Cas+Imdev 2400mg IV	Phase 2 Cohort 2: Placebo IV	Phase 2 Cohort 3: Placebo IV	Phase 2 Cohort 3: Cas+Imdev 2400mg IV	Phase 3 Cohort 1: Cas+Imdev 2400mg IV	Phase 3 Cohort 1: Placebo IV	Phase 2 Cohort 3: Cas+Imdev 8000mg IV	Phase 3 Cohort 1: Cas+Imdev 8000mg IV
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 198 (0.00%)	1 / 20 (5.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 206 (0.00%)	0 / 204 (0.00%)	0 / 197 (0.00%)	0 / 202 (0.00%)	0 / 205 (0.00%)	0 / 54 (0.00%)	0 / 56 (0.00%)	0 / 51 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 246 (0.41%)	0 / 247 (0.00%)	1 / 11 (9.09%)	2 / 246 (0.81%)
Vascular disorders
Haematoma
subjects affected / exposed	0 / 198 (0.00%)	0 / 20 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 206 (0.00%)	0 / 204 (0.00%)	0 / 197 (0.00%)	0 / 202 (0.00%)	0 / 205 (0.00%)	0 / 54 (0.00%)	0 / 56 (0.00%)	0 / 51 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 246 (0.00%)	0 / 247 (0.00%)	0 / 11 (0.00%)	0 / 246 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0
Nervous system disorders
Peroneal nerve palsy
subjects affected / exposed	0 / 198 (0.00%)	0 / 20 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 206 (0.00%)	0 / 204 (0.00%)	0 / 197 (0.00%)	0 / 202 (0.00%)	0 / 205 (0.00%)	0 / 54 (0.00%)	0 / 56 (0.00%)	0 / 51 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 246 (0.00%)	0 / 247 (0.00%)	1 / 11 (9.09%)	0 / 246 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Skin and subcutaneous tissue disorders
Drug eruption
subjects affected / exposed	0 / 198 (0.00%)	0 / 20 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 206 (0.00%)	0 / 204 (0.00%)	0 / 197 (0.00%)	0 / 202 (0.00%)	0 / 205 (0.00%)	0 / 54 (0.00%)	0 / 56 (0.00%)	0 / 51 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 246 (0.00%)	0 / 247 (0.00%)	0 / 11 (0.00%)	0 / 246 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Psychiatric disorders
Delirium
subjects affected / exposed	0 / 198 (0.00%)	0 / 20 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 206 (0.00%)	0 / 204 (0.00%)	0 / 197 (0.00%)	0 / 202 (0.00%)	0 / 205 (0.00%)	0 / 54 (0.00%)	0 / 56 (0.00%)	0 / 51 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 246 (0.00%)	0 / 247 (0.00%)	0 / 11 (0.00%)	1 / 246 (0.41%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1
Infections and infestations
COVID-19
subjects affected / exposed	0 / 198 (0.00%)	1 / 20 (5.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 206 (0.00%)	0 / 204 (0.00%)	0 / 197 (0.00%)	0 / 202 (0.00%)	0 / 205 (0.00%)	0 / 54 (0.00%)	0 / 56 (0.00%)	0 / 51 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 246 (0.00%)	0 / 247 (0.00%)	0 / 11 (0.00%)	0 / 246 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Enterocolitis infectious
subjects affected / exposed	0 / 198 (0.00%)	0 / 20 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 206 (0.00%)	0 / 204 (0.00%)	0 / 197 (0.00%)	0 / 202 (0.00%)	0 / 205 (0.00%)	0 / 54 (0.00%)	0 / 56 (0.00%)	0 / 51 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 246 (0.00%)	0 / 247 (0.00%)	0 / 11 (0.00%)	0 / 246 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Urinary tract infection
subjects affected / exposed	0 / 198 (0.00%)	0 / 20 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 206 (0.00%)	0 / 204 (0.00%)	0 / 197 (0.00%)	0 / 202 (0.00%)	0 / 205 (0.00%)	0 / 54 (0.00%)	0 / 56 (0.00%)	0 / 51 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	1 / 246 (0.41%)	0 / 247 (0.00%)	0 / 11 (0.00%)	1 / 246 (0.41%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1
Metabolism and nutrition disorders
Hyperglycaemia
subjects affected / exposed	0 / 198 (0.00%)	0 / 20 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 206 (0.00%)	0 / 204 (0.00%)	0 / 197 (0.00%)	0 / 202 (0.00%)	0 / 205 (0.00%)	0 / 54 (0.00%)	0 / 56 (0.00%)	0 / 51 (0.00%)	0 / 12 (0.00%)	1 / 12 (8.33%)	0 / 246 (0.00%)	0 / 247 (0.00%)	0 / 11 (0.00%)	1 / 246 (0.41%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

07 Aug 2020

To broaden patient eligibility and better align with the evolving epidemiology of when patients present to the hospital relative to COVID-19 symptom onset. To enroll patients at earlier stages of the disease and enable broader assessment of treatment impact on viral burden and other measures.

21 Dec 2020

The primary purpose of this amendment is to update the planned statistical analysis for the phase 1/2 portion of the study prior to unblinding.

07 Jul 2021

The primary purpose of this amendment is to update the planned statistical analysis for the final analysis, including changes to the objectives and endpoints, following early termination of the study

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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Clinical trials

Clinical Trial Results: A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients with COVID-19

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Time-weighted Average (TWA) Change in Viral Load in Nasopharyngeal (NP) Samples Based on Seronegative mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on High Viral Load mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 through Day 29 Based on Seronegative mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 through Day 29 Based on Seronegative mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on overall mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 6 Through Day 29 Based on overall mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on High Viral Load mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Seronegative mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS

Primary: Pooled Analysis (Phase 3 [Cohort 1] and Phase 2 [Cohort 1A]): Percentage of Participants Who Died or Went on Mechanical Ventilation From Day 1 Through Day 29 Based on Overall mFAS

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Treatment-Emergent Serious Adverse Events

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Treatment-Emergent Serious Adverse Events

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Grade >=2 Infusion Related Reactions up to Day 4

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Grade >=2 Infusion Related Reactions up to Day 4

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Grade >=2 Hypersensitivity Reactions Up to Day 29

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Number of Participants with Grade >=2 Hypersensitivity Reactions Up to Day 29

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on Seronegative mFAS

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS

Primary: Pooled Analysis (Phase 1 [Cohort 1] and Phase 2 [Cohort 1]): Cumulative Incidence of Death or Mechanical Ventilation Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 Through Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 1 Through Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Were Discharged by Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants who Were Discharged by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants who Were Discharged by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital Over Time Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died or Were Readmitted to Hospital by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death (ie, Overall Survival) by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Cumulative Incidence of Death or Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on High Viral Load mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS

Secondary: Pooled Analysis Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Time to Discharge From Hospital Based on Seronegative mFAS

Secondary: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Treatment-Emergent Serious Adverse Events

Secondary: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Treatment-Emergent Serious Adverse Events

Secondary: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Grade >=2 Infusion Related Reactions up to Day 4

Secondary: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Grade >=2 Infusion Related Reactions up to Day 4

Secondary: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Grade >=2 Hypersensitivity Reactions Up to Day 29

Secondary: Pooled Analysis (Phases 1/2/3 [Cohort 1] and Phase 2 [Cohorts 1A/2/3]): Number of Participants with Grade >=2 Hypersensitivity Reactions Up to Day 29

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Went on Mechanical Ventilation by Day 29 Based on Seronegative mFAS

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 through Day 29 Based on Seronegative mFAS

Secondary: Phase 3 (Cohort 1) and Phase 2 (Cohort 1A): Percentage of Participants Who Died From Day 6 through Day 29 Based on Seronegative mFAS

Clinical Trial Results:
A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients with COVID-19